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1. Theodros F. Medicine Assessor

2. Objective To describe Pharmaceutical product regulation in Ethiopia To describe the Major Regulatory Functions of the NMRA (EFDA) To describe the basic Registration AND Market Authorization Requirements. To describe the role of pharmacists in the Regulation of Pharmaceuticals and Medical Devices

3. Pharmaceutical Products Regulation Why we need to regulate these products? Pharmaceutical products are heavily regulated in order to protect and promote public health . Government agencies throughout the world have responsibility for supervising medical products on their market and regulating the activities of the pharmaceutical industries.

4. Accordingly, EFDA is established by law to regulate medical products through the Food and Drug A dministration proclamation No. 1112/2019. Because: it is necessary to prevent and control public health from health hazards caused by unsafe food; it is necessary to prevent and control public health from unsafe, ineffective and poor quality drugs, and medical devices; it is necessary to prevent and control public health from unsafe, and poor quality cosmetics. To regulate the rational use of drugs.

5. http://www.efda.gov.et /

6. EFDA Organizational Structure

7. Drug Sector Organogram

8. MD Sector Organogram

9. Regulatory Functions

10. Registration Medicine Registration is one of the most important function of a National Regulatory Authority. It helps to institute a system which subjects all pharmaceutical products to:- Pre-market Evaluation Mar k et Authorization Post-market Review To ensure that they conform to the required quality, safety and effectiveness.

11. Legal Basis 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.

12. 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 .

13. 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

14. 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

15. What is Registration? The process of reviewing and assessing dossiers for the quality, safety and efficacy o f a product against the authority’s medicine registration guidelines. The guidelines provide recommendation on the information for active pharmaceutical ingredient (API) and finished pharmaceutical product (FPP) that should be submitted to the Authority.

16. Registration Process

17. Registration Timeline ( b ased on five year experience) If complete information is submitted according to the requirements, MA can be granted:- WHO-PQ………..30 days SRA………………..30 days Own Assessment………120-180 days.

18. What Activities Done by Inspection Pre-license Inspection of premises Importers and distributors Wholesalers Shall scale manufacturers Large scale manufacturing Industries Good manufacturing Practice Inspection (Local and Foreign) “Good Manufacturing Practice (GMP)” means a part of quality assurance which ensures medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the marketing Authorization or product specification. Post-mar k eting Surveillance Waste Deposal control

19. Inspection Inspection of establishments across the medical product supply chain is an essential regulatory function. The supply chain includes manufacturers, distributors, re‐packagers, re‐labelers, importers, agents, traders, wholesalers and retailers of medical products. The purpose of regulatory inspections is to ensure that operations at these establishments are carried out in accordance with approved standards, norms, and guidelines and are in compliance with the national medical products legislation and regulations.

20. Type and Frequency of GMP Inspection Routine Inspection 1 ) Routine inspection shall be a full review of all aspects and components of GMP within a facility. 2 ) Routine inspection shall be conducted under an announcement when a newly established manufacturing facility or a manufacturer who has expressed interest of expanding manufacturing activities including, introduction of new products, modification of manufacturing methods or processes; or changes in key personnel, premises and/or equipment and When GMP certification has expired within 5 years.

21. Follow up Inspection 1 ) Follow up inspection shall be conducted specifically to monitor the result of corrective actions of the manufacturer following a previous inspection. 2) Any applicant shall apply only for two round follow up inspection.

22. Sudden Inspection 1 ) A sudden inspection shall be undertaken to do spot checks which could focus on one product, a group of related products, or a specific operation. 2 ) A sudden inspection shall be conducted when there are complaints about a specific product that suggest a defect, when there is a product recall due to adverse drug reaction, Post Market Surveillance, to gather specific information, or to investigate specific operations of the manufacturing processes and it shall not be announced.

23. Frequency of inspection 1 ) Manufacturers sites shall be inspected once every 5 year for the purpose of registration of their products.

24. What Activities Done by Pharmacovigilance The World Health Organization (WHO) has defined PV as “ the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other possible drug-related problems .” The aim of the PV system is to protect the public from medicines-related harm . Vaccines (AEFI) Biologics Drugs Medical devices Cosmetics

25. Conducting passive and active pharmacovigilance on:- Medicine related adverse events Product Quality Defect Medication error Drug interactions False positive or negative test results

26. Adverse drug event “Any untoward medical occurrence that may be present during treatment with a medicine but does not necessarily have a causal relationship with this treatment, that is, an adverse outcome that occurs while the patient is taking the medicine but is not, or not necessarily, attributable to it .” Adverse drug reaction "A response to a medicine which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function ."

27. Signal “is a Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously.” “ Usually more than one report is required to generate a signal, depending on the seriousness of the event and the quality of the information .”

28. Stakeholders that are involved A range of stakeholders are involved in pharmacovigilance activities: Patients and consumers • Healthcare professionals • Health facilities • Market Authorization Holders (MAH) • Public health programmes • EFDA(FMHACA ), responsible for that marketed medicines are safe and of quality for the public • Academia and research institutions • Professional Associations • WHO Collaborating Center for International Drug Monitoring • Community leaders • Media

29. Quality Control Physical Test Chemical Test Microbiological test Premarket Test Consignment test Post-marketing surveillance test Illegally captured drugs test

30. Pharmacist’s Role for Distribution and Control of Drug Products A fundamental purpose of pharmaceutical services in any setting is to ensure the safe and appropriate use of drug products and drug-related devices. Fulfillment of this responsibility is enhanced through the pharmacist’s involvement in all aspects of the use of drugs . This involvement should include decisions and actions with respect to the evaluation, procurement, storage, distribution, and administration of all drug products.

31. Questions for Review A quality control department wants to inspect community pharmacies randomly beyond inspection program:- Programed Inspection Sudden Inspection Scheduled Inspection Annual Inspection.

32. A quality control department wants to inspect the m anufacturing quality of the drug manufacturer. What the inspector inspects? Good Laboratory Practice Good Dispensing Practice Good Manufacturing Practice Good Procurement Practice

33. An auditor wants to audit your pharmacy store, during auditing he has got discrepancies recommends you to reconcile this discrepancies, you cannot reconcile. What is the problem (Lacing)? Double Counting Documentation

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35. CITIZEN CHARTER /FM H ACA

36. Based on guideline for submission of post approval variation medicine application for replacement or addition of the site where batch control/testing takes place needs to adhere to these condition Except:- A. Site has approval from EFDA to conduct quality control testing of finished pharmaceutical product concerned. B. The site is accordingly approved for GMP/GLP by the NDRA. C. Transfer of the method from the old to the new site or to the new test laboratory has been successfully completed. D. The site is accordingly approved for GDP

37. One of the following is true about clinical trial to be conducted Nursing and pregnant women are a candidate to establish the safety of the drugs Persons under the age of 18 is a candidate to establish the safety of the drugs Prisoners and insane persons are not forced and used in the clinical trials Clinical trial is conducted even if it is not authorized by the executive organ

38. ............................ is the type of inspection undertaken to ensure the fulfillment of requirement by pharmaceutical establishment before a license is issued. A .Pre-licensing inspection B .Post-licensing inspection C . Routine Inspection D. Special Inspection

39. Why is “license” needed for health professional ? A. To ensure proper management and utilization of pharmaceuticals. B. To ensure the fulfillment of requirements/ standards. C. To ensure the quality, safety and efficacy of pharmaceuticals. D . All

40. Inspection is A. verification of performance and data B. Determination of conformity to specified requirements C. Observation of premises, product, professional and practice D. All

41. Which of the following is not a ground for revocation of license? A. Drug addiction B . Mental illness C .Physical condition D .Violation of law governing the sector E . none

42. Which of the following is true about documentation content regarding change of dimensions of tablets, capsules, suppositories or pessaries without change in qualitative or quantitative composition and mean mass A. Detailed drawing or written description of the current and proposed appearance. B. Samples of the finished pharmaceutical product. C. Justification for not submitting a new bioequivalence study according to the current guidelines on bioequivalence D. All E . None

43. Which of the following is the responsibility of health professionals in pharmacovigilance ? A. Healthcare professionals should monitor for medication errors whilst prescribing, transcribing, dispensing and administering medicines to patients. B. Health professionals should make physical inspections of the medicinal product to be dispensed or administered C. If an ADR is suspected, the patient should be informed about the suspicion of the ADR and what actions are planned D. Report as soon as possible E . All

44. Which of the following is NOT true about the responsibility of marketing authorization holders (MAH) in pharmacovigilance. A. pharmaceutical industry, importer, wholesaler and distributor has the prime responsibility to monitor safety of their marketed products B. Serious ADRs, unexpected and expected, must be reported as soon as possible but no later than 60 calendar days of initial receipt of the information by the MAH. C. Non-serious ADRs must be sent within 120 days after he/she granted knowledge of the event. D. For new medicines, a Periodic Safety Update Report (PSUR) should be submitted to FMHACA every 6 months the first two years after market approval and thereafter annually for three years.