(2001; 96 pages) [French] [Spanish]
8.4 Stepwise approach to drug registration
A drug registration system is a major element of national legislation and regulation, and its administration is one of the key DRA functions. Since it is costly and labourintensive it is best developed in stages. Various registration procedures require different levels of technical expertise and resources. Countries can use the following procedures in the stepwise development of a drug registration system.
Step 1: Notification procedure
This can be used in countries where the drug registration system is just starting. The procedure involves recording standard information about all the pharmaceutical products offered for sale in a country. A drug register or drug list is produced, but no judgement is made about the products. The procedure does not involve checking whether drugs meet basic safety, efficacy and quality criteria, but it provides a useful basis for developing additional control and improving the registration system. Some countries require registration of a product in the country of origin or in some other specified countries.
Step 2: Basic authorization procedure
Drugs listed in the register are provisionally authorized to remain on sale. However, every new drug that is to be sold requires a licence, which is issued after assessment of efficacy, safety and quality, as well as of the accuracy and completeness of the packaging information. The DRA has various options:
• It can make its own assessment of the quality, safety and efficacy of the product on the basis of information submitted by the applicant. This must be done for products manufactured in the country.
• It can use assessment protocols from DRAs in other countries as a basis for making decisions about applications.
• It can rely on decisions made by DRAs in other countries. For imported products, this can be done by using the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.47 This indicates whether the product has been registered, whether the product information has been approved by the DRA of the exporting country, and whether the manufacturer conforms to guidelines for GMP. However, not all DRAs are equally well developed and a certificate can never be more reliable than the authority that issues it.
Step 3: Full registration
This involves detailed evaluation of the data submitted before marketing authorization for a pharmaceutical product is granted. This process will decide the indications for a product’s use and whether it can be dispensed with or without a prescription. It also involves post-marketing surveillance and periodic review of registration.
Step 4: Re-evaluation of older drugs
All older drugs are systematically reassessed. This could result in a revocation or non-renewal of the registration if there is new information about the product, for example regarding a serious adverse reaction, or if the product no longer meets the efficacy, safety and quality requirements for registration. Most countries have a limited registration period (usually five years). At the end of the period, an application for renewal of registration has to be submitted if the manufacturer wants to continue marketing the product.