hfhurh

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
Administration 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
EFDA
General Director
Food Sector
Deputy DG
Drug Sector
Deputy DG
Medical
Device Sector
Deputy DG
QA
Head of QA

7. Drug Sector Organogram
Drug
Sector
Drug Evaluation and
Registration Department
Drug Inspection and
Enforcement Department
Quality Control
Department
Pharmacovigilance and
Clinical Trial Department

8. MD Sector Organogram
MD
Sector
MD Evaluation and
Registration Department
MD Inspection and
Enforcement Department
MD Quality Control
Department

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
– Market 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:
1. 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.
2. 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 of 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
Application Reception
Check the formal validity of the application
Dossiers can be submitted prior to GMP inspection
Assessment
Quality (Chemistry, Manufacturing and control)
Interchangeability/Safety and efficacy
Product Information (Labeling, SmPC and PIL)
Outcome
The ultimate outcome of the registration process will
be either denial or marketing authorization of the
product .

17. Registration Timeline
(based 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-marketing 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:-
A. Programed Inspection
B. Sudden Inspection
C. Scheduled Inspection
D. Annual Inspection.

32. • A quality control department wants to inspect
the manufacturing quality of the drug
manufacturer. What the inspector inspects?
A. Good Laboratory Practice
B. Good Dispensing Practice
C. Good Manufacturing Practice
D. 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)?
A. Double Counting
B. Documentation

34. ???

35. CITIZEN CHARTER /FMHACA

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
A. Nursing and pregnant women are a candidate
to establish the safety of the drugs
B. Persons under the age of 18 is a candidate to
establish the safety of the drugs
C. Prisoners and insane persons are not forced and
used in the clinical trials
D. 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.