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Chapter One: Introduction to pharmaceutical
regulation (World, Africa, Ethiopia)
Elias S. (BA.Acc ,B.Pharm.)
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Drug Regulatory Affairs
INTRODUCTION
Definition
Drug Regulatory Affairs is a function which regulates the pharmaceutical
market/science in order to facilitate trade / business in and outside the
country of origin for public interest.
It is a unique mix of science and management to
achieve a commercially important goal within a drug development
organization.
Can add significant impact for patients and drug companies
Drug Regulatory Affairs regulate pharmaceutical business through
designing appropriate laws (rules) and enforcing the laws so that the drugs
meeting the highest standards of Quality are brought into the Global Trade.
Rules and regulations are being prepared considering Global, Regional and
National pharmaceutical trade as well as necessity of the drugs based on
patient population
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INTRO..
Regulatory affair is a comparatively new profession which developed from the
desire of governments to protect public health by controlling the safety and efficacy
of products in areas including: pharmaceuticals, medical devices, Tobacco, Food, &
cosmetics and complementary medicines.
Activities in medicine regulation
Licensing of the manufacture, import, export, distribution, promotion and advertising
of medicines
Assessing the safety, efficacy and quality of medicines, and issuing marketing
authorization for individual products
Inspecting and surveillance of manufacturers, importers, wholesalers and dispensers of
medicines
Controlling and monitoring the quality of medicines on the market
Controlling promotion and advertising of medicines
Monitoring safety of marketed medicines including collecting and analyzing adverse
reaction reports
Providing independent information on medicines to professionals and the public
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Unfortunate events that catalysed the development
of medicines regulation
• Unfortunate events have catalysed the development of medicines
regulation more than the evolution of a knowledge base.
1. vaccines tragedy happened in 1901:
• The diphtheria antitoxin (contaminated by tetanus)
• smallpox vaccine administered was found contaminated
2. Diethylene glycol poisoning:
• In 1938 over 100 people in the United States died of following the
use of a sulfanilamide elixir, which used the chemical as a solvent
without any safety testing.
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CONT..
3. Thalidomide disaster:
• The other catastrophe that influenced the development of medicines
regulation far more than any event in history was the thalidomide disaster
• Thalidomide was a sedative-hypnotic that first went on sale in Western
Germany in 1956. Between 1958 and 1960 it was introduced in 46
different countries worldwide resulting in an estimated 10,000 babies
being born with phocomelia
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Roles of regulatory affairs professionals
• Regulatory Affairs advisor plays important portfolio in Health Authority
as well as Pharmaceutical Industry.
Role of Regulatory Affairs Professionals in Health Authorities
• Evaluation of Marketing Authorization Application ( MAA) i.e.
• New Drugs Application,
• New Biologics Application,
• Medical Device and Cosmetics application,
• Generic Application,
• Clinical Trial Application,
• Variation Application,
• Drug Master Files for API,
• Excipients and Packaging Materials,
• Site Master File for GMP inspection.
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Regulatory Affairs and its Role in Pharmaceutical Industry
• A regulatory affair (RA) is a profession which acts as the interface
between pharmaceutical industry and drug regulatory authorities across
the world.
• It is mainly involved in the registration of drug products in respective
countries prior to their marketing.
• Regulatory Affairs is actively involved in every stage of development of
a new medicine and in the post marketing activities with authorised
medicinal products.
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Different countries regulatory body
Some of the important organizations working as drug regulatory authorities’ are:
European Medicine Agency (EMEA) – Europe union
Medicines and Healthcare products of Regulatory Agency – UK
Food and Drug Administration (FDA) – USA
Drug Controller General of India (DCGI) - India
Ethiopian Food & Drug Authority (EFDA)- Ethiopia
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EMEA
• The EMEA is a decentralized body of the European Union with headquarters in
London.
• Its main responsibility is the protection and promotion of public and animal
health, through the evaluation and supervision of medicines for human and
veterinary use.
• The EMEA is responsible for the scientific evaluation of applications for
European marketing authorization for medical products (centralized procedure).
• Under the centralized procedure, companies submit a single marketing
authorization application to EMEA.
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DRUG REGISTRATION
• Registration of drugs, also known as product licensing or marketing
authorization, is an essential element of drug regulation.
• All drugs that are marketed, distributed and used in any given
country should be registered by the national competent regulatory
authority.
• Only the inspection of manufacturing plants and laboratory
quality control analysis certainly does not guarantee product
quality and safety.
• Drug regulation should therefore include the scientific
evaluation of products before registration, to ensure that all
marketed pharmaceutical products meet the criteria of safety,
efficacy and quality.
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DRUG REGISTRATION
• When marketing authorization is granted(issued) for medicines along with a set of
clinical information including indications are approved.
• The use of medicines for indications that have not been approved by a
regulator is called ‘off-label’ use.
• This means that the safety and efficacy of medicines for these indications has not
been assessed and approved by a regulator.
• One of the most common off-label use areas is pediatric medicine.
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REGISTRATION OF INNOVATIVE MEDICINES
• Innovative medicines (originator products) are new medicines that have
not been used in humans earlier and contain new active ingredients
(usually expressed using INN system).
• Nowadays these medicines are usually first approved by regulators in well
resourced countries using regulatory requirements harmonized in the
framework of International Conference on Harmonization of Technical
Requirements for the Registration of Pharmaceuticals for Human Use
(ICH)
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CONT…
• The terms of reference for ICH include to maintain a forum for constructive
dialogue between regulatory authorities and the pharmaceutical industry on
the real and perceived differences in the technical requirements in the EU,
USA and Japan in order to ensure:
• a more timely introduction of new medicinal products, and their
availability to patients,
• to monitor and update harmonized technical requirements leading to a
greater mutual acceptance of research and development data
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CONT…
• The ICH technical Topics are divided into four major categories
• Q Topics
• means ‘Quality’ Topics
i.e., those relating to chemical and pharmaceutical Quality Assurance
(examples: Q1 Stability Testing, Q3 Impurity Testing).
• S Topics
• S means ‘Safety’ Topics,
• i.e., those relating to in vitro and in vivo preclinical studies.
examples: S1 Carcinogenicity Testing, S2 Genotoxicity Testing).
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• E Topics
• E means ‘Efficacy Topics,
• i.e., those relating to clinical studies in human subject (examples: E4 Dose
Response Studies,, E6 Good Clinical Practices).
• M Topics
• M designates ‘Multidisciplinary’ Topics
• i.e., cross-cutting Topics which do not fit uniquely into one of the above
categories (examples: M1 Medical Terminology, M2 Electronic Standards
for Transmission of Regulatory Information)
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CONT….
• As more than 95% of new medicines are worked out in the ICH “regions”
the technical requirements for the safety, efficacy and quality of new
medicines is determined at large by ICH technical guidelines.
• The application format for registration (marketing authorization) of new
medicines in ICH and associated countries has to follow The Common
Technical Document (CTD) which provides harmonized structure and
format for new product aplications.
• What is CTD ?
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Role of WHO in Drug Regulation
• WHO is the directing and coordinating authority for health within the United
Nations system.
• It is responsible for:
• providing leadership on global health matters,
• shaping the health research agenda,
• setting norms and standards,
• Articulating(giving) evidence-based policy options,
• providing technical support to countries and
• monitoring and assessing health trends.
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African Medicines Regulatory Harmonization (AMRH)
It established to ensure that African people have access to
essential medical products and technologies.
AMRH programme started in 2009 as a response to
addressing challenges faced by National Medicine
Regulatory Authorities (NMRAs) in Africa.
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Medicine regulation in Ethiopia
• Different proclamations and regulations has
passed for the regulation of the pharmaceuticals
in Ethiopia.
1.The Pharmacists and Druggists proclamation No 43/1942
2. Pharmacy Regulation No. 288/1964
3.Proclamation No. 176/1999 (DACA)
4.Proclamation No. 661/2009 (EFMHACA)
5.Proclamation No. 1112/2018 (EFDA)
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The 1942 Proclamation was the basis for pharmaceutical regulation
Where both pharmacists and druggists together with the facilities where they practiced
were regulated.
Comprehensive regulation of the pharmaceutical sector was started in
the early stages of 1964.
By the development of a regulation called Pharmacy Regulation No. 288/1964
this regulation formed the legal basis for official establishment of medicine regulation in
the history of Ethiopia
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Current EFDA
Proclamation No1112/2018
• “Food and Medicine Administration Proclamation No1112/2018”
• a proclamation to provide for food and medicine administration in
Ethiopia
• Currently approved by council of ministers and approved by the house of
peoples representatives
The Ethiopian Food and Drug Administration (EFDA) regulates the
introduction of more than 12,000 unique items into the Ethiopian
pharmaceutical supply chain.
