Drug regulatory authorities

Missions of drug regulatory authorities of selected countries... 

Table 5.3 Overview of human resources in the drug regulatory authorities... 

Table 5.4 Overview of drug regulatory authorities financial resources... 

Lack of funding is mentioned as a problem for the drug regulatory authorities in Tunisia and Venezuela. Inadequate facilities for regulation, due to a lack of funds for the purchase of equipment, were cited by Cyprus, Malaysia and Uganda. 

The mechanisms provided for transparency and accountability of the drug regulatory authorities in the 10 countries are listed in Table 5.7. These mechanisms are summarized below according to the group for whose benefit accountability is sought. 

Table 5.7 Mechanisms used by drug regulatory authorities to ensure transparency and accountability...

Only three countries, Tunisia, Uganda and Zimbabwe, do not issue a GMP certificate. The drug regulatory authorities in these three countries do conduct GMP inspections, but do not issue a specific document which indicates that a manufacturing plant has attained GMP standards. The MCAZ does, however, provide a GMP certificate at the manufacturer s request to facilitate international registration and export of products. In Malaysia, various types of certificates are issued GMP certificates Certificate of Pharmaceutical Product for export and Certificate of Free Sale for medical devices and cosmetic products. Cyprus has no clear criteria for issuing a GMP certificate instead. 

Notification or approval by the drug regulatory authority not required. 

Direction de la Pharmacia et du Medicament [Pharmacy and Medicines Directorate] (Tunisia) drug regulatory authority... 

ICDRA International Conference of Drug Regulatory Authorities... 

The EudraNet (Em opean Union drug regulatory authorities network) is an Internet working serviee provided to EU medieinal regulatory authorities in eollabora-... 

This introduction of the CTX scheme is widely cited as an example of the benefits of deregulation. Australian drug regulatory authorities subsequently also introduced a similar scheme. 

Every country needs an authoritative, independent, competent and reliable system for evaluating adverse reactions to drugs and vaccines - a system that is linked with and provides support for the national drug regulatory authority (NRA) and for the national ministry of health. More than 80 countries... 

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