Fundamentals of Regulation ethiopian food and drug authority.pptx

regulation

1. Theodros Fenta (Bpharm, MSc) Head, Biological Medicine Evaluation Desk Office of Medicine Evaluation and Market Authorization Ethiopian Food and Drug Authority Fundamentals of Medical Product Regulation and Regulation principles

2. Outline Medical Product Regulation principles Ethiopian Regulatory History Current Ethiopian Regulatory System

3. Objective After the completion of this training you will be able to: Understand the principles of medicine regulation The regulatory system of Ethiopia

4. Fundamentals of Regulation and Principles Why we need to regulate medical products? Medical products are heavily regulated in order to protect and promote public health . Everybody wants to be able to receive medical treatment if they are ill. Therefore, medicines are needed that are effective against the illness. Unfortunately, all medicines come with unwanted side effects . Irrespective of where they originate from, medicines on the market must be safe for normal use. Medicines must be reliable. This means that they must be manufactured according to high quality standards. All these points are addressed through regulation.

5. Conti… Therefore, government agencies throughout the world have responsibility for supervising medical products on their market and regulating the activities of the pharmaceutical industry.

6. Conti… The first duty of a national regulatory authority (NRA) is to register pharmaceutical products , thus defining the pharmaceutical market in the country. Only when this has been done, it will be possible to distinguish between legally traded products and illegal and counterfeit ones . WHO QA of pharmaceuticals, 1997

7. Conti… The fundamentals of medicine regulation involve a comprehensive framework designed to ensure the safety, efficacy, and quality of medicines. This framework includes: Pre-Market Evaluation : Rigorous scientific assessment of a medicine’s safety, efficacy, and quality before it can be approved for use. Clinical Trials : Testing of the medicine in human subjects to gather data on its safety and effectiveness. Manufacturing Standards : Ensuring that medicines are produced consistently and in compliance with quality standards. Post-Marketing Surveillance : Monitoring the safety of medicines after they have been released to the market, including tracking adverse events and implementing necessary actions if safety concerns arise. Regulatory Guidelines : Adherence to international and national guidelines and regulations. Legal Framework : Compliance with legal requirements for the authorization, manufacture, and distribution of medicines, as outlined in various regulations and directives

8. Global Regulatory History The concepts of how medicines should be tested and regulated have evolved very gradually over time, perhaps dating back to Babylonian Era in the 2 nd millennium. The thalidomide disaster and its immediate aftermath Thalidomide is a sedative and hypnotic that first went on sale in West Germany in 1956. Between 1958 and 1960 it was introduced in 46 countries under 51 different trade names. This use in early pregnancy was soon followed by an epidemic of a previously unknown congenital malformation of the limbs termed ‘ phocomelia.

9. Conti… Thalidomide was soon confirmed as a potent teratogen in animal studies. The first animal in which this characteristic congenital malformation was reproduced was the New Zealand white rabbits.

10. Conti… Then, several countries set a regulatory requirements for new medicines such as: To secure adequate pharmacological and safety testing and clinical trials of new medicines before their release for general use; To secure early detection of adverse effects arising after their release for general use; and To keep healthcare professionals informed of the experiences of such medicines in clinical practice.

11. Ethiopian Regulatory History Historically, pharmaceutical regulation was started in 1942 by "The Pharmacists and Druggists Proclamation No. 43/1942“. Comprehensive regulation of the pharmaceutical market and overall practice was introduced in 1964 by a regulation called "Pharmacy Regulation No. 288/ 1964". Sultan S. et al, 2016

12. Ethiopian Regulatory History Then, since the past few decades, the regulatory system has passed through a continuous reform.

13. Ethiopian Food and Drug Authority

14. EFDA’s Mission and Vision EFDA’s Mission is to protect and promote public health by ensuring the safety, effectiveness, quality and proper use of regulated products through:- Licensing, inspection, registration, laboratory testing, Post-marketing surveillance, community participation, and Provision of up-to-date regulatory information. Vision

15. Quality Policy Statement

16. Ethiopian Regulatory System Components Administrative Elements Policy, legislation, regulation Human Resource Finance Infrastructure Technical Elements Standards Specifications Guidelines Procedures Regulatory Functions Regulation Level Federal Regional Zonal Woreda

17. Officially Accepted Standards Int. Phar, USP, JP, BP and Phar.Eur are officially accepted pharmacopeias by EFDA

18. Medicine Registration Article 20, FDA Proc 1112/2019 states: Any medicine and medical device shall not be manufactured, imported, distributed, transported, sold, hold, used, or transfer to any other person without registration and marketing authorization. The executive organ shall register and grant marketing authorization in accordance with sub-article (1) of this article after it assesses the quality, safety and efficacy of the medicine, or the medical device.

19. Conti… 3. The provisions of sub-article (1) of this article shall not apply in respect of the sale of any medicine compounded by a pharmacist for a particular patient…, or any medicine or medical device imported for use by a particular patient as per a prescription…. 4. Any medicine or medical device shall be registered if the manufacturer complies with good manufacturing practices , dossiers are evaluated and found to fulfil quality, safety, and efficacy , and as appropriate fulfils laboratory quality test requirements .

20. Conti… 5. Notwithstanding to the provision of sub-article (1) of this article, the executive organ may, in compelling circumstances, grant a permit for the importation or use of unregistered medicine or medical device. e.g. Natural or man made crisis SARS-CoV2-2019 pandemic War related crisis

21. Conti… 6. Every medicine or medical device registered in accordance with this proclamation shall have its registration renewed every five years . Market authorization Validity 5 years Renewal period 180 days before expiry

22. Risk Based Regulation The rigor of regulatory assessment of medicines shall be commensurate with the product’s type, nature, and potential risk to human health. (Article 19)

23. Product Lifecycle Regulation: the EFDA context GMP Production and Control by MAH Pharmacovigilance Inspection

24. Use of External Review Panels This information will be reviewed by NDAC This information will be reviewed by the Medicine Assessor of EFDA

25. Use of external Review Panels Working collaboratively with Addis Ababa and Jimma Universities: in the assessment of dossiers Evidence generation Capacity building

26. EFDA’s Presence EFDA’s Head Quarter is located in Addis Ababa Wollo-Sefer Area near to Bole Printing Press

27. EFDA’s Presence Branch Offices EFDA has seven branch offices which are strategically located at the different corners of the country. There are also 17 entry and exit ports. control what is coming in and going out

28. EFDA’s Presence Branch offices They administer and control pharmaceuticals in the surrounding areas Work closely with nearby regional regulators. Coordinate the nearby entry and exit ports They also perform quality control tests. We are constructing vaccine and other biological product testing center in Hawassa Branch Office.

29. EFDA Recent Achievements Establishing a well functioning quality management system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. Exercising strong leadership that contributed significantly to key milestones in tobacco control. ENAO ISO 17025:2012- Accredited inspection and enforcement system ANAB ISO 17025:2017- Accredited Quality Control Laboratory

30. EFDA Current Endeavors

31. Future Prospects EFDA will continue working on GBT requirements to achieve the highest levels (ML3 & ML4) and strengthen the regulatory system for continuous improvement.

32. Future Prospects

33. Challenges The challenges in medicine regulation are multifaceted and vary across different contexts. Here are some key challenges: Limited Resources : Many regulatory agencies face constraints in terms of human resources, funding, and infrastructure. This can hinder their ability to effectively oversee the entire lifecycle of medicines, from pre-market evaluation to post-marketing surveillance. Complexity of Science and Technology : Advances in medical science and technology create challenges for regulators. Keeping up with rapidly evolving fields such as nanomedicine, precision medicine, and biologics requires continuous learning and adaptation of regulatory frameworks. Globalization and Harmonization : As pharmaceutical supply chains become more global, harmonizing regulations across countries becomes crucial. However, achieving consensus on standards and practices can be challenging due to differing priorities, legal systems, and cultural contexts.

34. Conti… Balancing Innovation and Safety : Regulators must strike a delicate balance between promoting innovation and ensuring patient safety. Expedited pathways for drug approvals can lead to potential risks if not carefully managed. Data Privacy and Security : With the increasing use of electronic health records and data-driven approaches, protecting patient privacy and preventing data breaches are critical challenges. Regulations need to address these concerns effectively. Adaptive Pathways : The traditional linear drug development process is being challenged by adaptive pathways, which allow for iterative development based on real-world evidence. Regulators need to adapt their frameworks to accommodate these new approaches.

35. Conti… Post-Marketing Surveillance : Detecting adverse events and monitoring the safety of medicines after they are on the market is essential. However, resource limitations can hinder robust post-marketing surveillance systems. Counterfeit Medicines : The proliferation of counterfeit drugs poses a significant risk to public health. Regulators must enhance mechanisms to detect and prevent the circulation of fake or substandard medicines.

36. Conti… Access to Essential Medicines : Ensuring equitable access to quality medicines remains a challenge, especially in low-resource settings. Regulatory systems need to address affordability, availability, and accessibility. Changing Landscape : The pharmaceutical industry is constantly evolving, with new therapeutic modalities (such as gene therapies and cell-based treatments) emerging. Regulators must adapt to these changes while maintaining rigorous standards.

37. Thank You