Objectives and achievements of regulations in developing countries
A major objective for most developing countries is to ascertain what is on the market and to prepare an inventory. Developing countries have adopted different methods to register drugs.
The role of the WHO Certification Scheme on the Quality of Pharmaceutical Products, in assisting countries to develop and update registration systems, has not yet been fully appreciated.
In formulating the criteria for drag registration, some countries are under pressure to adopt a ‘need clause’ as in Norway. However, given adverse balance of payments and other foreign exchange problems, more and more countries are likely to consider the price of the drug as a critical factor in the registration process.
Whilst modest attempts are underway to develop the local production of drugs, lack of resources for the enforcement of good manufacturing practice is a major impediment.
In many developing countries there is an urgent need to improve supply systems and this has resulted in diverting scarce resources which could have been deployed for regulatory purposes.
Countries with limited resources need to be encouraged to develop innovative regulatory systems which are tailor-made to local needs.
KeywordsGood Manufacturing Practice Regulatory Decision Certification Scheme Essential Drug Bulk Drug
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