Skip to main content Skip to search Skip to main navigation

WHO: 2 More African Countries Reached Maturity Level 3

The World Health Organisation (WHO) announced that Senegal had became the 7th country and Rwanda the 8th country to achieve the status of a stable, well-functioning regulatory authority for the regulation of medicines in Africa.

Both countries reached Maturity Level 3 (ML3) in WHO's global classification of national regulatory authorities. Maturity Level 3 indicates a stable, well-functioning, and integrated regulatory system. Maturity Level 4, the highest level, signifies an advanced regulatory system committed to ongoing improvement.

This designation follows formal benchmarking by WHO, marking significant progress toward regulatory system strengthening on the continent. Other countries at ML3 in Africa are Egypt, Ghana, Nigeria, South Africa, Tanzania and Zimbabwe.


Source:

WHO: News

 

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

FDA: Pilot Program for One-Day Inspectional Assessments

FDA: Pilot Program for One-Day Inspectional Assessments

Since April 2026, the U.S. FDA has been piloting “One-Day Inspectional Assessments” as a complement to standard FDA inspections.
Read more
EU: Commission Implementing Regulation on QM and Conformity Assessment Activities of Notified Bodies

EU: Commission Implementing Regulation on QM and Conformity Assessment Activities of Notified Bodies

Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 further specifies requirements for notified bodies under the MDR and IVDR frameworks and aims to promote a more harmonised implementation across the European Union.
Read more
The ABC of User Requirements Specification (URS)

The ABC of User Requirements Specification (URS)

In the URS, the future user defines what the system should be capable of, but also what it is limited to. In addition to the (testable!) technical requirements, regulatory require-ments should also be taken into account.
Read more
What is the Importance of Data Integrity?

What is the Importance of Data Integrity?

Here's the answer:
Read more
EDQM: Updated Guideline on CEP Revisions and Renewals

EDQM: Updated Guideline on CEP Revisions and Renewals

The European Directorate for the Quality of Medicines & HealthCare has published a revised version of its guideline on the revision and renewal of Certificates of Suitability (CEPs) (PA/PH/CEP (04) 02), aligning it with recent EU legislation on variation procedures.
Read more
EMA: Public Consultation of Annexes to ICH Q3C and VICH GL18 on Residual Solvents

EMA: Public Consultation of Annexes to ICH Q3C and VICH GL18 on Residual Solvents

The European Medicines Agency (EMA) has published revised annexes to the ICH Q3C guideline (“Impurities: Guideline for Residual Solvents”) and the corresponding veterinary guideline VICH GL18 for public consultation. The commenting period is open until the end of June 2026.
Read more
Previous
Next