(1997; 248 pages) [French]
5. Collaboration between drug regulatory authorities
Bilateral or multilateral collaboration between drug regulatory authorities assists countries with limited resources. Sharing responsibilities in assessment and increasing mutual cooperation provide a wider spectrum of expertise for evaluation. Harmonization of the registration requirements for generics of the various drug regulatory authorities can accelerate the approval process. Furthermore, an agreed mechanism of quality assurance in relation to the assessment work of collaborating agencies is vital.