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PHARMACY LAWS & ETHICS
PHP 402
Lecture 7
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COURSE OUTLINE
• Overview
• Introduction to Regulatory Affairs & Regulatory Bodies.
• Ethical principles & Pharmacy Laws.
• Practice of Pharmacy Profession
• Pharmaceutical Establishments
• Registration of Pharmaceutical Products
• Rules regulating handling of Psychotropic drugs.
• The Law of Intellectual Proprietary Rights (IPR) (No 82/2002)
• Syndicates Laws (No 47/1969)
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REGISTRATION OF PHARMACEUTICAL PRODUCTS
A public pharmacy can only SELL registered
products.
A licensed factory can only PRODUCE registered
products.
The registration procedure has undergone several
changes in the last few years in Egypt.
Registration is a slow process (may be 3 - 4 years).
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REGISTRATION OF PHARMACEUTICAL PRODUCTS
Which authority is NOW responsible for registration?
or
???
‫اإلدارة المركزية للمستحضرات الحيوية والمبتكرة والدراسات اإلكلينيكية‬
‫اإلدارة المركزية للمستحضرات الصيدلية‬
‫اإلدارة المركزية للمستلزمات الطبية‬
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REGISTRATION OF PHARMACEUTICAL PRODUCTS
• General Considerations of Registration.
• Types of Registration.
• Registration Procedure.
• Decision regarding registering the pharmaceutical product.
• Re-registration procedure.
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General Considerations of Registration
• All pharmaceuticals in Egypt are subject to mandatory EDA pricing by a "Pricing
Committee".
• The "High Technical Committee" is responsible for the final issue of a registration
number.
➢ The High Technical Committee is responsible for any major decision concerning
Pharmaceutical Products in Egypt.
➢ This committee is formed by the 127/1955 law and is formed of:
✓
The Head of EDA as the Head of the Committee.
✓
9 members:
A faculty of pharmacy professor.
A director of the Institute of Research and Tropical
Medicine in MoH.
Standing Committee for the Pharmacopoeia
representative.
A faculty of medicine professor.
An EPS pharmacist representative
(not an EPS employee).
A government pharmacist specialized in
drug analysis
An MoH pharmacist
representative.
An EMS Physician representative
(not an EMS employee).
A government pharmacist specialized in
biological analyses
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Types of Registration
1. Local.
2. Under-license.
3. Toll (or contract manufacturing).
4. Imported.
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Types of Registration
1.
Local: Generics registered by Egyptian companies that own factories. These generics must
have similar foreign product in a reference country (e.g. USA- European Union – Australia Canada and Japan).
2.
Under-license: Products registered by Egyptian companies that own factories & has a
contract with a foreign company to manufacture the product with the foreign company’s
specifications and supervision.
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Types of Registration
3. Toll (or contract manufacturing): Generics registered by companies that do NOT own
factories & have a contract with other Egyptian companies that own factories & have the
capacity to produce for others.
4. Imported: Products registered by an importing company or a scientific office to be imported
from a foreign company in a reference country (USA- European Union- Australia- Canada
and Japan).
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Registration Procedure
An official registration form is filled by the company & includes the following:
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Registration Procedure
An official registration form is filled by the company & includes the following:
Concentration and dosage form of the product.
20 suggested trade names.
Photocopy of the reference of the product: BNF, USP, Swiss Compendium etc…
Company name and address.
Registration type ?!
Full composition (formula) of the product (active and inactive ingredients, including composition of the capsule shell in case of capsules).
The packs of the products (size and material).
Shelf life of the product and storage conditions.
Indications and dosage.
Raw material specifications.
Labels for the product (outer and inner packaging) in English and Arabic.
The factory license, stating the presence of the production line suitable for the dosage form of the product.
In case of new companies: include a report from the EDA Central Administration for Operations (Licensing section) about the current status of the factory and the production lines.
The product will not acquire a marketing authorization until the factory is licensed.
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The possibility of registering will be studied according to the following rules
➢ The EDA allowing the registration of 12 similar products (the innovator plus 11 generic
versions, one of which may be imported).
➢ A limit of 12 similar products is also imposed for “high technology” products
(innovator plus 11 generics, of which no more than five may be imported).
➢ An exception to the twelve similar products will be given if the application is for a line
extension.
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ADDITIONAL DOCUMENTS TO BE INCLUDED IN THE FILE
1. For imported products and products manufactured under license:
✓ Original Certificate of Free Sale (CFS) (or any equivalent certificate, e.g. the WHO certificate) including:
commercial name of the product, full composition (formula) it must be exactly the same as composition of the
product to be launched in Egypt.
✓ Name and address of the foreign company.
✓ Statement that this company is manufacturing according to GMP regulations. The certificate must be legalized
by the Egyptian Embassy.
✓ Copy of the agreement between the foreign (mother) company and the Egyptian company legalized by the
Egyptian Embassy, clearly stating the name of the product under registration.
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ADDITIONAL DOCUMENTS TO BE INCLUDED IN THE FILE
2. For toll manufactured products:
→ a copy of the agreement between product owner and the manufacturer.
✓ The product owner (or one of the co-owners) must be a pharmacist.
✓ The agreement between product owner and the manufacturer must state clearly the mutual responsibility of
both parties for: quality of the final product, import of raw materials complying with the international
specifications, the storage, the analysis and all the manufacturing steps until the final product is produced.
✓ The product owner must be a member of the Pharmaceutical Chamber of Industry.
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• The High Technical Committee will issue a
conditioned approval for registration of the
pharmaceutical product.
• The High Technical Committee will issue a
marketing authorization and a registration
number after certain steps.
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1. Analysis by Drug Control Laboratories.
2. Bioequivalence Studies.
3. Stability Studies.
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1. Analysis by Drug Control Laboratories
→ 3 batches within 2 years of the approval.
➢ Inspector from the EDA Central Administration of Operations (Inspection
section) will witness the actual production in the factory.
➢ The inspector takes samples from these 3 batches and send them to drug
control laboratories.
➢ Other samples are used for Bioequivalence and Stability studies.
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DRUG CONTROL
LABORATORIES FILE
1. Specifications of the finished product.
2. Analytical certificate of the finished product.
3. Test method(s) for the finished product.
4. Specifications of active and inactive raw material(s) with
reference to the corresponding pharmacopeias- if
applicable.
Drug control laboratories must complete the analysis
of the samples within 45 working days of receiving the
samples.
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2. Bioequivalence Studies
✓ For a drug to be bioequivalent to its innovator’s product, it must deliver the same amount of the
active ingredient(s) in the same amount of time as the original.
✓ But inactive ingredients, flavors, fillers and dyes may be different.
✓ The study must be approved by the High Technical Committee.
✓ Exception to this is the products with any of the following certifications: FDA, EMEA, WHO.
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3. Stability Studies
Two types of stability study:
A. Accelerated at high temperature 40 oC/75% R.H.
B. Real time at room temperature – for Egypt 30 oC
The validity period is approved by High Technical Committee
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1. Decision regarding registering the pharmaceutical
product will be studied by the corresponding scientific
committees if the product contains :
A. New chemical entity.
B. New combination.
C. Old molecule with new use, dose or dosage form.
In these cases, the company must submit the following:
✓ Pre-clinical data on animals (toxicological – cellular
transformation- teratogenicity- carcinogenicity- …)
✓ Clinical studies on volunteers and patients..
✓ Bioavailability study.
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2. Imported products with any of the following
certifications: FDA, EMEA, WHO:
•
will acquire a temporary registration number from
the High Technical Committee before the import.
•
The product will not be launched until the
random samples from the imported first 3 batches
(can be in the same shipment) are analyzed by
Drug Control Laboratories (within 45 days).
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3. Personal Importing → It is permitted for patients to import
rare pharmaceutical products that are not available in Egypt.
• Only a limited number of units is permitted for personal use
only. The patient must apply for permission from EDA.
•
Explosive products need extra permission from the Ministry
of Interior.
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RE-REGISTRATION
Pharmaceutical products
Every 10 years
Dietary Supplements and Biological products
Every 5 years
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Nutraceuticals
➢ Nutraceuticals are natural products with mild pharmacological activity,
formulated in dosage form (tablets - capsules – syrups) as well as
multivitamin preparations that have quantities of vitamins less than the
RDA.
➢ Nutraceutical Committee →To evaluate and approve new nutraceuticals to
be introduced to the Egyptian market.
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