Regulatory Compliance Comprehensive Pharmaceutical Regulatory Services Your Partner in Achieving Market Compliance Discover a suite of pharmaceutical regulatory services meticulously designed to navigate the complex African market landscape. From Registration Strategies to Marketing & Sales, our modular services are meticulously crafted to align with your market entry and growth aspirations. Tailored for Your Success Our Service Spectrum All Services ​Regulatory Intelligence Regulatory Consulting and Quality Assurance MC Pharma (Pty) Ltd is licensed under Section 22C(1)(b) of Act 101 (the Medicines and Related Substances Act 101, of 1965), and conducts various services to assist entities in operating the medical industry. Regulatory affairs consultancy and registration services include, but not limited to: Learn More Section 21 ​Authorisation Granted by SAHRPA MC Pharma can assist with import and supply of unregistered orthodox medicine or veterinary medicine into Africa on a Section 21 basis. Learn More Import & Export Services Distribution & Wholesale MC Pharma has agreements with major distributors and wholesalers: Import and Export logistics. Management of local warehousing and distribution. Key Accounts Liaison. Learn More New Business Development ​Business Development Services Proactively seeking new business opportunities. Research new opportunities and manage the company entry and development strategy. Building business relations with current and potential clients. Doing extensive research on all potential markets, products and potential clients. Liaison with client and regulatory bodies for registration of products. Maintaining short- and long-term business development plan. Learn More Sales and Marketing Sales & Marketing Team Sales reporting and analysis. Development of Marketing aids to suit Reps needs. Documentation and detailing of products, new product launches in market. Advertising Compliance and Certification. Dedicated and experienced sales reps. Marketing and design. Market analysis. Learn More Our Products Suite Compliant, Reliable, and Market-Ready Explore our range of products, each engineered to meet the rigorous regulatory standards of the pharmaceutical landscape in South Africa. Our Products Medical Products Explore our range Medical products already approved for South African market. Our Products Adverse Drug Reactions Prioritizing Patient Safety and Regulatory Compliance Adverse Drug Reactions (ADRs) are a critical concern in the pharmaceutical industry. MC Pharma places paramount importance on understanding, managing, and reporting ADRs to ensure patient safety and adhere to regulatory standards for products registered on our license. Learn More Strategic Partnering With the Future in Mind Our aim is to become your strategic partner by understanding your strategic objectives, identifying the critical aspects of your business plans and matching the appropriate solutions to those plans Our Partners

Your Trusted Partner in Africa Market Entry to Market Leadership Navigating Regulatory Paths, Building Market Leadership A seamless journey, with MC Pharma, your partner in sales, marketing and tenders in Africa Book Consultation Our affiliations from reputable bodies affirm our competence and commitment to adhering to the highest standards of regulatory compliance. Our Affiliations MC Pharma is a specialist pharmaceutical company, adept in navigating the complex regulatory environment, ensuring that products meet the stringent compliance requisites of African markets. Who We Are Expertise Rooted in Experience Learn More From Registration Strategies to Marketing & Sales, our modular services are meticulously crafted to align with your market entry and growth aspirations. Tailored for Your Success Our Service Spectrum All Services ​Regulatory Intelligence Regulatory Consulting and Quality Assurance Sales and Marketing We have a passionate and innovative Sales & Marketing Team that delivers a spectrum of services Import & Export Services Distribution and Wholesale New Business Development ​Business Development Services Our Products Suite Compliant, Reliable, and Market-Ready Explore our range of products, each engineered to meet the rigorous regulatory standards of the pharmaceutical landscape in South Africa. Our Products Medical Products Explore our range Medical products already approved for South African market. Our Products Industry Insights Stay Updated, Stay Ahead Dive into the latest updates and trends in the pharmaceutical industry to keep your operations compliant and competitive. All Articles Adverse Drug Reaction Reporting Ensuring Patient Safety Report adverse drug reactions promptly, aiding in the continuous effort to uphold patient safety and product efficacy. Approach ADR's Correctly Connect With Us Your Success, Our Priority Reach out to our team of seasoned professionals to discuss how MC Pharma can facilitate your pharmaceutical market entry and compliance journey in Africa. Contact Us Our Partners Collaborative Growth Meet our global partners who have leveraged MC Pharma’s expertise for successful market entry and regulatory compliance in Africa. Partners Our Global Footprint International Collaborations Beyond our local partnerships, MC Pharma is also connected with a network of global partners, expanding our reach and capability in delivering comprehensive pharmaceutical solutions across borders. Become Global

Terms & Conditions MC Pharma's Learn More Terms and Conditions Welcome to www.mcpharma.co.za (the "Website"). These Terms and Conditions ("Terms") govern your use of the Website operated by MCPharma (Pty) Ltd. ("us," "we," or "our"). Please read these Terms carefully before accessing or using our Website. By accessing or using any part of the Website, you agree to be bound by these Terms. If you do not agree to all the Terms, then you may not access the Website. ​ 1. Intellectual Property The content on this Website, including text, graphics, logos, images, audio clips, digital downloads, data compilations, and software, is the property of MCPharma (Pty) Ltd. and is protected by intellectual property laws. You may not use, reproduce, modify, distribute, or display any portion of this Website without our express written consent. ​ 2. User Responsibilities You agree to use the Website in accordance with all applicable laws and regulations. You are solely responsible for any content you submit to the Website and for ensuring that your use of the Website does not violate the rights of any third party. ​ 3. Account Information If you create an account on our Website, you are responsible for maintaining the confidentiality of your account and password. You agree to accept responsibility for all activities that occur under your account. You must notify us immediately if you believe that your account information has been compromised. ​ 4. Third-Party Links Our Website may contain links to third-party websites that are not owned or controlled by MCPharma (Pty) Ltd. We have no control over, and assume no responsibility for, the content, privacy policies, or practices of any third-party websites. You acknowledge and agree that MCPharma (Pty) Ltd. shall not be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the use of or reliance on any such content, goods, or services available on or through any third-party websites. ​ 5. Disclaimer of Warranties The Website is provided on an "as-is" and "as-available" basis. MCPharma (Pty) Ltd. makes no warranties, expressed or implied, and hereby disclaims and negates all other warranties, including without limitation, implied warranties or conditions of merchantability, fitness for a particular purpose, or non-infringement of intellectual property or other violation of rights. ​ 6. Limitation of Liability In no event shall MCPharma (Pty) Ltd., its directors, officers, employees, or agents be liable for any indirect, incidental, special, consequential, or punitive damages, including without limitation, loss of profits, data, use, goodwill, or other intangible losses, resulting from (i) your use or inability to use the Website; (ii) any unauthorized access to or use of our servers and/or any personal information stored therein; (iii) any interruption or cessation of transmission to or from the Website; (iv) any bugs, viruses, trojan horses, or the like that may be transmitted to or through the Website by any third party; or (v) any errors or omissions in any content or for any loss or damage of any kind incurred as a result of your use of any content posted, emailed, transmitted, or otherwise made available via the Website, whether based on warranty, contract, tort, or any other legal theory. ​ 7. Governing Law These Terms shall be governed by and construed in accordance with the laws of South Africa. Any disputes arising under or in connection with these Terms shall be subject to the exclusive jurisdiction of the South African courts. ​ 8. Changes to Terms and Conditions MCPharma (Pty) Ltd. reserves the right to update, change, or replace any part of these Terms at any time. It is your responsibility to check this page periodically for changes. Your continued use of or access to the Website following the posting of any changes constitutes acceptance of those changes. ​ 9. Contact Information If you have any questions about these Terms, please contact us: By email: pharmacist@mcpharma.co.za By visiting this page on our website: https://www.mcpharma.co.za/contact Effective date: 01/01/2024

Propel Your Brand in Africa Pharmaceutical Sales and Marketing Strategies Tailored for Success MC Pharma excels in crafting and executing innovative sales and marketing strategies, ensuring your pharmaceutical brand achieves notable recognition and growth in the competitive African market. Sales Reporting and Analysis Send Market Analysis Send Dedicated and Experienced Sales Reps Send Marketing and Design Send Advertising Compliance and Certification Send New Product Launches in Market Send Ready to elevate your brand in Africa? Connect with MC Pharma for bespoke sales and marketing strategies that promise a journey of growth and market dominance. ​ Contact Us Today Ignite Your Sales and Marketing Journey Contact Us

Seamless African Market Entry Your Trusted Partner in Imports & Exports Let Us Navigate Africa for You Navigate the African pharmaceutical market with ease through MC Pharma’s adept Import and Export services, tailored to ensure a seamless market entry and compliance. Import and Export Logistics Send Management of Warehousing Send Distribution Management Send Key Accounts Liaison Send Get in touch with our team of seasoned professionals to discuss how MC Pharma can accelerate your pharmaceutical market entry in South Africa through adept imports and exports services. Beyond the Basics Understand Your Import and Export Journey Contact Us

Privacy Policy MC Pharma's Learn More Privacy Policy MCPharma (Pty) Ltd. ("us", "we", or "our") operates the www.mcpharma.co.za website (the "Service"). This page informs you of our policies regarding the collection, use, and disclosure of personal data when you use our Service and the choices you have associated with that data. ​ We use your data to provide and improve the Service. By using the Service, you agree to the collection and use of information in accordance with this policy. Unless otherwise defined in this Privacy Policy, terms used in this Privacy Policy have the same meanings as in our Terms and Conditions, accessible from www.mcpharma.co.za . Information Collection And Use We collect several different types of information for various purposes to provide and improve our Service to you. Types of Data Collected Personal Data While using our Service, we may ask you to provide us with certain personally identifiable information that can be used to contact or identify you ("Personal Data"). Personally identifiable information may include, but is not limited to: Email address First name and last name Phone number Address, State, Province, ZIP/Postal code, City Cookies and Usage Data ​ Usage Data We may also collect information on how the Service is accessed and used ("Usage Data"). This Usage Data may include information such as your computer's Internet Protocol address (e.g. IP address), browser type, browser version, the pages of our Service that you visit, the time and date of your visit, the time spent on those pages, unique device identifiers, and other diagnostic data. ​ Tracking & Cookies Data We use cookies and similar tracking technologies to track the activity on our Service and hold certain information. Cookies are files with a small amount of data which may include an anonymous unique identifier. Cookies are sent to your browser from a website and stored on your device. Tracking technologies also used are beacons, tags, and scripts to collect and track information and to improve and analyze our Service. You can instruct your browser to refuse all cookies or to indicate when a cookie is being sent. However, if you do not accept cookies, you may not be able to use some portions of our Service. Examples of Cookies we use: Session Cookies. We use Session Cookies to operate our Service. Preference Cookies. We use Preference Cookies to remember your preferences and various settings. Security Cookies. We use Security Cookies for security purposes. Use of Data MCPharma (Pty) Ltd. uses the collected data for various purposes: To provide and maintain the Service To notify you about changes to our Service To allow you to participate in interactive features of our Service when you choose to do so To provide customer care and support To provide analysis or valuable information so that we can improve the Service To monitor the usage of the Service To detect, prevent and address technical issues ​ Transfer Of Data Your information, including Personal Data, may be transferred to — and maintained on — computers located outside of your state, province, country, or other governmental jurisdiction where the data protection laws may differ from those of your jurisdiction.If you are located outside South Africa and choose to provide information to us, please note that we transfer the data, including Personal Data, to South Africa and process it there. ​ Your consent to this Privacy Policy followed by your submission of such information represents your agreement to that transfer.MCPharma (Pty) Ltd. will take all steps reasonably necessary to ensure that your data is treated securely and in accordance with this Privacy Policy, and no transfer of your Personal Data will take place to an organization or a country unless there are adequate controls in place, including the security of your data and other personal information. ​ Disclosure Of Data Legal Requirements MCPharma (Pty) Ltd. may disclose your Personal Data in the good faith belief that such action is necessary to: To comply with a legal obligation To protect and defend the rights or property of MCPharma (Pty) Ltd. To prevent or investigate possible wrongdoing in connection with the Service To protect the personal safety of users of the Service or the public To protect against legal liability ​ Security Of Data The security of your data is important to us, but remember that no method of transmission over the Internet, or method of electronic storage is 100% secure. While we strive to use commercially acceptable means to protect your Personal Data, we cannot guarantee its absolute security. ​ Service Providers We may employ third-party companies and individuals to facilitate our Service ("Service Providers"), to provide the Service on our behalf, to perform Service-related services, or to assist us in analyzing how our Service is used. These third parties have access to your Personal Data only to perform these tasks on our behalf and are obligated not to disclose or use it for any other purpose. ​ Links To Other Sites Our Service may contain links to other sites that are not operated by us. If you click on a third-party link, you will be directed to that third party's site. We strongly advise you to review the Privacy Policy of every site you visit. We have no control over and assume no responsibility for the content, privacy policies, or practices of any third-party sites or services. ​ Changes To This Privacy Policy We may update our Privacy Policy from time to time. We will notify you of any changes by posting the new Privacy Policy on this page. We will let you know via email and/or a prominent notice on our Service, prior to the change becoming effective and update the "effective date" at the top of this Privacy Policy. You are advised to review this Privacy Policy periodically for any changes. Changes to this Privacy Policy are effective when they are posted on this page. ​ Contact Us If you have any questions about this Privacy Policy, please contact us: By email: pharmacist@mcpharma.co.za By visiting this page on our website: https://www.mcpharma.co.za/contact Effective date: 01/01/2024

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Pharmaceutical Regulatory Intelligence Regulatory Excellence, Quality Assured Your Bridge to Compliance and Market Success MC Pharma's Regulatory Affairs and Quality Assurance services serve as a catalyst, ensuring your pharmaceutical journey is compliant, quality-driven, and market-ready. 1 Compiling and submission of ZA-eCTD applications for Medicines, Medical Devices and Health Products 2 eCTD compilation, submission and full CTD life-cycle management including updates and amendments. 3 Package insert and patient information leaflet development. 4 Registration gap-analysis data reporting. 5 Site Master File (“SMF”) in accordance with the Preparation of a Site Master File Guideline (4.08). 6 Import/Export and Distribution logistics of regulated pharmaceuticals 7 Development of Quality Management System (“QMS”) in compliance with GLP 8 Quality Manual 9 Standard Operating Procedures 10 Application for South African National Accreditation System (SANAS) GLP Certification Regulatory and Quality Assurance Your Quality Assurance Advocate Upholding Quality, Ensuring Compliance MC Pharma's Quality Assurance services epitomize a commitment to superior quality, ensuring your products meet the stringent regulatory standards while upholding the trust and confidence of your stakeholders. Contact Us Equip Yourself with Regulatory Knowledge Resources for Informed Decision-Making Access a reservoir of educational resources on Regulatory Affairs and Quality Assurance, arming you with the knowledge for informed decision-making in your pharmaceutical journey. Industry News Regulatory and Quality Experts Initiate Your Compliance Journey Elevate your compliance standards by engaging with MC Pharma's Regulatory and Quality Assurance experts. Contact us to initiate your journey towards market success with uncompromised quality. Book Consultation Regulatory Affairs Consulting and Management Send Tailored Quality Assurance Strategies Send Your Bridge to Compliance and Market Success Send Navigation of Regulatory Pathways Send Explore MC Pharma's multifaceted approach to Regulatory Affairs and Quality Assurance, tailored to meet the rigorous standards of the pharmaceutical industry while aligning with your strategic objectives. Quality Assurance Tailored to Your Needs Comprehensive Regulatory Pharmaceutical Services All Services FAQ's Your Queries Addressed What are regulatory pharmaceutical services? As a specialist pharmaceutical company that offers regulatory pharmaceutical services to help pharmaceutical companies comply with regulatory requirements and guidelines. These services include regulatory consulting, regulatory writing, regulatory submissions, and regulatory compliance1 . Why are regulatory pharmaceutical services crucial for drug manufacturers? Regulatory pharmaceutical services are crucial for drug manufacturers because they help ensure that the drugs they produce are safe, effective, and meet regulatory requirements. MC Pharma’s regulatory pharmaceutical services help drug manufacturers navigate the complex regulatory landscape and ensure that their products are approved for sale in the market . How do regulatory pharmaceutical services aid in drug approvals? MC Pharma’s regulatory pharmaceutical services aid in drug approvals by providing support throughout the drug development process. These services help drug manufacturers prepare and submit regulatory documents, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biologics License Applications (BLAs). They also help manufacturers comply with regulatory requirements and guidelines throughout the drug development process . What is the scope of regulatory pharmaceutical services? The scope of MC Pharma’s regulatory pharmaceutical services includes regulatory consulting, regulatory writing, regulatory submissions, and regulatory compliance. These services help drug manufacturers comply with regulatory requirements and guidelines throughout the drug development process . Which companies offer the best regulatory pharmaceutical services in South Africa? As the industry leader in regulatory pharmaceutical services in South Africa. Their services are highly sought after by pharmaceutical companies in the region. MC Pharma’s regulatory pharmaceutical services are known for their quality, reliability, and effectiveness . How do regulatory pharmaceutical services ensure compliance with SAHPRA? MC Pharma’s regulatory pharmaceutical services ensure compliance with SAHPRA by helping drug manufacturers navigate the complex regulatory landscape and ensuring that their products meet regulatory requirements. These services help manufacturers prepare and submit regulatory documents, such as IND applications, NDAs, and BLAs, and comply with regulatory requirements and guidelines throughout the drug development process . What are the costs associated with regulatory pharmaceutical services? The costs associated with MC Pharma’s regulatory pharmaceutical services vary depending on the type of service required and the complexity of the project. MC Pharma offers competitive pricing for their services and ensures that their clients receive value for their money . How do regulatory pharmaceutical services differ from clinical trial services? Regulatory pharmaceutical services differ from clinical trial services in that they focus on regulatory compliance and drug approvals, while clinical trial services focus on conducting clinical trials. MC Pharma’s regulatory pharmaceutical services help drug manufacturers comply with regulatory requirements and guidelines throughout the drug development process, while clinical trial services help manufacturers conduct clinical trials to test the safety and efficacy of their products . Can international companies avail regulatory pharmaceutical services in South Africa? Yes, international companies can avail MC Pharma’s regulatory pharmaceutical services in South Africa. MC Pharma has a wealth of global clients in countries such as the UK, Australia, France, Germany, Brazil, China, India, and the USA . What are the challenges faced by regulatory pharmaceutical services? Some of the challenges faced by regulatory pharmaceutical services include navigating the complex regulatory landscape, keeping up with changing regulations and guidelines, and ensuring that products meet regulatory requirements. MC Pharma’s regulatory pharmaceutical services have a proven track record of overcoming these challenges and ensuring that their clients’ products are safe, effective, and meet regulatory requirements . 1 We purchase the stock 2 We import the stock 3 We pay the yearly retention fees to SAHPRA 4 We will share all the post importation testing and transport validation reports with the principle 5 Adverse reactions (PV) report will be sent to DRCONSULTING and the principle 6 We are liable to keep the dossier updated as to SAHPRA requirements If MC Pharma Has Sole Distribution Rights

Your Trusted Regulatory Pharmaceutical Company Pioneering Regulatory Excellence Prioritizing Patient Safety and Regulatory Compliance Embark on a journey with MC Pharma, a regulatory pharmaceutical company dedicated to steering your health products through the complex regulatory landscape in Africa. Our Mission MC Pharma serves as a reliable connection between pharmaceutical innovation and the global market, providing proactive assistance in a constantly evolving international landscape. We prioritize healthcare excellence, respect, and diversity, fostering collaboration and innovation for timely medication access and healthcare advancement. Simplifying Regulatory Complexities Our Vision Our commitment is to safeguard and enhance patient health by consistently delivering pharmaceutical products and services of the highest quality, ensuring safety and efficacy that meet global customer expectations. We achieve this through the implementation of current good manufacturing practices, cutting-edge technology, a skilled workforce, and efficient management practices. Fostering Growth Our Story About Us Global Footprint MC Pharma has over 25 years of regulatory experience. From being part of the genesis of a number of industry associations, to being at the forefront of regulatory legislative changes, MC Pharma has been intimately involved in every aspect. MC Pharma staff boasts experience in Retail Pharmacy, Hospital and the Research spheres of the pharmaceutical industry. A strong background in Academia is also reflected in MC Pharma’s diligent regulatory processes. We pride ourselves in being at the cutting edge of international regulatory changes to assist our customers pro-actively adapt to the ever changing requirements and regulations. Paired with extensive knowledge of the pharmaceutical industry as a whole, from SAHPRA (South African Health Products Authority) submissions to business growth and management, MC Pharma can adapt to the dynamic needs of the client. We endeavor to find innovative solutions to any aspect of the pharmaceutical regulatory process, and to assist our clients reach their goals in a dynamic international market. MC Pharma (Pty) Ltd., is a specialist pharmaceutical company licensed in terms of Section 22C of the Medicines and Related Substances Act 101 of 1965, and offers the services of an Applicant and Holder of the Registration Certificate (Marketing Authorisation Holder), on behalf of a Principal or Product Owner. ​ MC Pharma has a combination of local licenses (DoH, SAPC, SAHPRA) thereby enabling us to act as contract Marketing Authorisation Holder (MAH) and local SAHPRA liaison on behalf of a principal or product owner. ​ Services offered: Regulatory Intelligence Sales and Marketing Section 21 Application Import and Exports New Business Development ​​ MC Pharma has, in addition to our local Clients, a wealth of global Clients in countries such as the UK, Australia, France, Germany, Brazil, China, India, Israel, China, and the USA. We endeavor to find innovative solutions in an ever-changing international market to assist our clients in reaching their goals. ​ MC Pharma has a national sales footprint and we cover the entire African market (South Africa, Namibia, Lesotho, Botswana and Swaziland), as well as most countries upon inquiry. ​ MC Pharma distributes through outsourced Distributors and Wholesalers. We have long-standing and trusted, pre-approved, relationships with reputable Distributors and 2 Wholesalers in Africa. Company Profile Upholding Regulatory Standards Immerse in MC Pharma’s profile, reflecting a robust foundation in regulatory affairs, market analysis, and strategic partnerships, all tailored to ensure your successful market entry. Form Partnership We are dedicated to delivering high-quality products and services. 01 We uphold unwavering integrity in all our actions. 02 We firmly believe in transparent and open communication. 03 We are staunch advocates for the empowerment of our people, fostering entrepreneurship, innovation, and accountability. 04 We actively practice non-discrimination and provide equal opportunities for all. 05 We hold profound respect for individuals, society, and the environment. 06 Our Values What We Stand For Tracy Burger Executive Chairman of the Board Junita Castle Executive Finance and Logistics Jaco Van Der Wath Executive Sales and Marketing Declan Burger Executive Compliance Meet The Executive Team Committed to Excellence Our values of integrity, innovation, and partnership remain the compass that guides our actions, fostering a culture of trust, adaptability, and collaborative growth. Connect With Us Your Product Success, Our Priority Get in touch with our team of seasoned professionals to discuss how MC Pharma can accelerate your regulatory compliance and market entry journey in Africa. Meet The Team Our Employees Our employees constitute our most valuable asset. We hold in high regard the unique creativity of each individual employee and cultivate an environment that aligns with our core values. The Team Our Customers Our commitment is to surpass the requirements and expectations of our customers in terms of value, quality, and service through our products and services. We aim to instill confidence in our customers by consistently being a fair and reliable partner. Surpass Expectations

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Reach Out To... Your Trusted Pharmaceutical Regulatory Partner Bridging Your Path to Market Compliance At MC Pharma, we value open communication and are keen on assisting you through your pharmaceutical regulatory journey in Africa. Contact us to discuss your needs and discover how our expertise can serve you. Ready to Explore Unmatched Regulatory Expertise? Your Regulatory Success, Our Priority Your inquiries are important to us. Fill out the form below or call us to discuss your pharmaceutical regulatory requirements. Our team is ready to provide the guidance and services you need. Contact Us Find us at our office address for a face-to-face consultation by appointment only. Our doors are open from Monday to Friday during regular business hours. We are looking forward to discussing your pharmaceutical regulatory projects. Book Your Personal Consultation With Us Our Office Location Visit Us Initiate Your Journey Toward Regulatory Excellence Your inquiries are important to us. Fill out the form below or call us to discuss your pharmaceutical regulatory requirements. Our team is ready to provide the guidance and services you need. First name* Last name* Email* Phone Are you a healthcare professional?* Yes No Other What services are you interested in?* ​Regulatory Intelligence Sales and Marketing Section 21 Import & Export Services New Business Development Other Subject Message I aknowledge and accept MC Pharma's T&C's and Privacy Policy Submit Get in Touch FAQ's Quick Answers to Your Queries Who are the leading pharmaceutical regulatory companies in South Africa? The South African Health Products Regulatory Authority (SAHPRA) is the regulatory authority of South Africa responsible for the regulation of health products intended for human and animal use; the licensing of manufacturers, wholesalers, and distributors of medicines and medical devices; radiation emitting devices and radioactive nuclides; and the conduct of clinical trials . How do pharmaceutical regulatory companies operate in South Africa? Pharmaceutical regulatory companies in South Africa are required to comply with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA) . The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines . What are the challenges faced by pharmaceutical regulatory companies in South Africa? The pharmaceutical regulatory environment in South Africa is complex and influenced by the country’s socio-economic paradigm. Some of the challenges faced by pharmaceutical regulatory companies in South Africa include poor regulatory environment, disparate regulatory requirements, uneven playing field, and inadequate financial resources . How do regulations impact pharmaceutical regulatory companies in South Africa? Regulations impact pharmaceutical regulatory companies in South Africa by requiring them to comply with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA) . The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines . What services do pharmaceutical regulatory companies offer in South Africa? Pharmaceutical regulatory companies in South Africa offer services such as strategic regulatory consulting, regulatory affairs and regulatory intelligence, registration pathways and license management services, end-to-end operational support, complete life cycle approach to CTD / eCTD dossier compilation and publishing, dossier preparation, review and management, regulatory submissions, medical writing, and more . How do pharmaceutical regulatory companies ensure drug safety in South Africa? Pharmaceutical regulatory companies in South Africa ensure drug safety by complying with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA) . The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines . What are the trends in pharmaceutical regulatory companies in South Africa? The trends and the market are changing constantly and an in depth and programmatic approach to analysing the data for each service and product requires an knowledgeable consultant to gather and compile. How do international pharmaceutical regulatory companies operate in South Africa? International pharmaceutical regulatory companies operate in South Africa by complying with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA) . The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP). All pharmaceutical manufacturers and wholesalers are required to comply with such guidelines . What is the future of pharmaceutical regulatory companies in South Africa? The future of pharmaceutical regulatory companies in South Africa is expected to be influenced by the establishment of the African Medicines Agency (AMA) which will significantly contribute to the improvement of regulatory systems in the Africa region . How do pharmaceutical regulatory companies collaborate with drug manufacturers in South Africa? Pharmaceutical regulatory companies in South Africa collaborate with drug manufacturers by ensuring that they comply with the regulations formed by the South African Health Products Regulatory Authority (SAHPRA) . The Authority requires that a pharmaceutical manufacturer or wholesaler be licensed to manufacture, which may include a licence to import and/or export medicines, or to act as a wholesaler of medicines. Guidelines are issued by the Authority, from time to time, which relate to various matters including Good Manufacturing Practices (GMP) or Good Distribution Practices (GDP).

Comprehensive Management of... Adverse Drug Reactions Prioritizing Patient Safety and Regulatory Compliance Adverse Drug Reactions (ADRs) are a critical concern in the pharmaceutical industry. MC Pharma places paramount importance on understanding, managing, and reporting ADRs to ensure patient safety and adhere to regulatory standards for products registered on our license. Stay Informed, Stay Safe Contact us to report products registered under our license Reach out to MC Pharma for expert guidance on Adverse Drug Reaction management. Our dedicated team is ready to assist you in navigating the complexities of ADR reporting and management, ensuring a safer pharmaceutical practice. Adverse Drug Reaction Form What Are Adverse Drug Reactions? The Implications of ADRs in Pharmaceutical Operations An adverse drug reaction is an unwanted or harmful reaction experienced following the administration of a medicine. Understanding the types, causes, and implications of ADRs is crucial for ensuring patient safety and regulatory compliance. Learn More Adverse Drug Reaction Assistance Form Adverse Drug Reaction Assistance Form for products registered on MC Pharma’s license First name* Last name* Email* Phone Product Name* Are you currently experiencing a reaction?* Yes No Please explain in as much detail as possible what reaction you are experiencing and what you think caused it.* Submit Reach Out For Assistance FAQ's What are adverse drug reactions? ADRs are unwanted, uncomfortable, or dangerous effects that drugs may have . They can be considered a form of toxicity . ADRs can occur due to overingestion (accidental or intentional) or to elevated blood levels or enhanced drug effects that occur during appropriate use . How do companies monitor adverse drug reactions? Companies monitor ADRs through various methods including formal drug safety studies, published data, pharmaceutical company data from periodic safety update reports (PSURs), and shared international data . They also use specific investigations and laboratory tests . What is the process to report an adverse drug reaction? The process to report an ADR involves healthcare professionals or patients reporting suspected adverse reactions to regulatory bodies . This can be done via specific software, email, fax, or post . How do adverse drug reactions impact drug approvals? ADRs can impact drug approvals as negative results are less likely to be published than positive results . Regulatory bodies may require additional information to establish the safety, quality, and efficacy of medicines . What are the most common adverse drug reactions reported? Common ADRs include upset stomach, dry mouth, and drowsiness . Digestive disturbances such as loss of appetite, nausea, bloating sensation, constipation, and diarrhea are also common . How can patients avoid adverse drug reactions? Patients can avoid ADRs by keeping a list of their medicines, following directions, asking questions, keeping up with any blood testing recommended by their doctor, and taking all medicines only as directed . What role do healthcare professionals play in monitoring adverse drug reactions? Healthcare professionals play a key role in monitoring ADRs. They are best placed to report suspected adverse reactions as part of patient care . How do regulations ensure the reporting of adverse drug reactions? Regulations ensure the reporting of ADRs by requiring manufacturers of prescription medical products to submit adverse event reports to regulatory bodies . Regulatory bodies may also request any additional information to establish the safety, quality, and efficacy of medicines . What are the challenges in monitoring adverse drug reactions? Challenges in monitoring ADRs include the increasing complexity of therapeutics, an ageing population, rising multimorbidity , and issues with pharmacovigilance systems such as lengthy and complicated reporting forms . How do companies ensure the safety of their drugs post-adverse reactions? Companies ensure the safety of their drugs post-ADRs through periodic, unannounced inspections of drug production and control facilities . If a drug has the potential for serious adverse effects, regulatory bodies may require that the manufacturer establish a Risk Evaluation Mitigation Strategy (REMS) to ensure that the benefits of the drug outweigh the risks .