Module 1 2021

25/06/2021

MEA: Overall Drug Registration Requirements

Compilation, Translation, Submission ● Country-specific local forms ● Technical documents accepted in French (Francophone countries) or English (Non-Francophone countries) ● Insert leaflet in English or French + local language ● Declaration & certificates (CMP/CPP, GMP, contracts):

must be legalized notarized or apostilled ● Pre-submission meeting not required

Review Process ● No clear indication of/abidance by time for review (exceptions e.g. Saudi Arabia) ● Timelines: vary a lot between countries

6 months in Bahrain

–

– 3-4 years in South Africa (improvement anticipated….)

43

The Organisation for Professionals in Regulatory Affairs

43

International Regulatory Challenges – Regulation and Guidance • High-level guidances only (generally) ● Still evolving – but currently not developed enough to provide specific guidance

● Requirements are not very transparent ● Intention in leading Brazil, Russia, India, China (BRIC) countries is to steadily improve over next few years – this has started • Ensuring a strategy to manage: ● Need senior RA people with deep knowledge and long-term working experiences ● Keep close eye on agency (Govt) movement ● Good professional relationships with agency officials ● Strong analysis on flexibility: regulation vs. reality ● Capability to forecast and communicate internally

The Organisation for Professionals in Regulatory Affairs 44

44

22