General procedures for drug export registration to various countries

A product can be marketed in international markets only after it is registered in that country. The registration approval is granted by the Health Authorities of the respective countries.

Registration process includes the following stages:

  • Company registration prior to product registration (which may also involve manufacturing facility inspection)

  • Plant approval which involves manufacturing facility inspection

  • Product registration which also includes sample analysis by the Health Authorities

  • Re-registration of product registration

1. Health Authorities of many countries insist on company registration, which may also include plant inspection prior to product registration. Only after the company is registered, the Health Authorities consider products for registration.

For instance, in Vietnam and Bahrain for company registration, only submission of documents is essential whereas in some countries like Oman, Ethiopia for company registration, submission of documents as well as inspection is essential.

For Company registration following documents need to be submitted :

  1. Name and address of the manufacturer along with telephone no., fax no.; email address
  2. Person responsible for the quality of the products of the manufacturer
  3. Manufacturing licence of the manufacturer
  4. Plant WHO-GMP certificate i.e. COPP (Certificate of Pharmaceutical Product)
  5. Statement of capital assets (i.e Annual report of the company)
  6. Number of employees in detail department wise (e.g. No. of employees in Quality control, Production, Stores, Administrative, R&D, etc.)  
  7. List of products manufactured by the company
  8. List of equipments/instruments in manufacturing, quality control and Research and development
  9. Research and development activities
  10. Prescription of Quality Control & Manufacturing areas, Production capacity.
  11. List of company patented products
  12. Status of registration in other countries (List of countries where company/products are registered)
  13. International approvals if any
  14.  Plant layouts

2. There are some other countries which do not insist on company registration but only plant approval. Inspections are conducted and a particular plant is approved for the specified dosage forms at that location. E.g. Tanzania, Uganda; South Africa, USA, etc.

Plant inspection is conducted by a team of experienced technical persons of the respective Health Authorities. During the inspection they see whether all the WHO-GMP requirements are fulfilled, whether the manufacturing facility, documents are as per latest pharmacopeial standards, etc.

3. In most of the countries, products are considered for registration directly. In these countries neither company registration is required nor plant approval is required. Every country has their own registration guidelines as per which the registration dossiers are submitted by the applicants.

The requirements for compilation of registration dossier are listed below :

  1. Application form
  2. WHO-GMP certificate of the product.
  3. Manufacturing licence of the product.
  4. Details of the product.
  5. Regulatory status in other countries.
  6. Manufacturing details : Manufacturing formula, Manufacturing process, Inprocess controls, Process validation if required.
  7. Active Pharmaceutical Ingredient (API): Properties of API, Route of synthesis, Specifications and Method of Analysis (pharmacopoeial or non-pharmacopoeial), Stability Data, Working standard along with Certificate of analysis.
  8. Specifications, Certificate of analysis of Inactive Ingredients.
  9. Finished Product Specifications, Method of analysis of Finished product, Stability data, Analytical Method Validation if required.
  10. Samples of Finished Product.
  11. Container / closure system(s) and other packaging specifications, samples of specimen packaging materials.
  12. Container labeling.
  13. Patient information and package insert.
  14. Medical data: Pharmacology, toxicology, efficacy of the product, Bioequivalence studies of the product, Clinical studies conducted  on the product, etc.

Health authorities of some countries require manufacturing data in detail wherein process validation, Batch manufacturing records, Development studies are expected as part of the dossier, e.g. USA, South Africa, Singapore, etc.

In some countries analytical section is required extensively like inclusion of analytical method validation, TLC/HPLC/IR chromatograms. e.g. Thailand, Singapore, Philippines, etc.

4.  Re-registration of the product is done as per the validity schedule of the product in the country. Dossiers are submitted for re-registration as per the guidelines of the respective country.