Skip to main content Skip to search Skip to main navigation

WHO: Recognition for Swissmedic and two other authorities

On 30 October 2023, the World Health Organization (WHO) recognized regulatory authorities as "WHO-Listed Authorities" for the first time. WHO-Listed Authorities (WLA) are regulatory authorities that operate in accordance with international standards and fulfil the requirements based on an established benchmarking and performance evaluation process.

The three authorities to receive this status are the Swiss Agency for Therapeutic Products Swissmedic, the Health Sciences Authority HSA, Singapore, and the Ministry of Food and Drug Safety MFDS, Republic of Korea. This means that Swissmedic, the HSA and the MFDS are considered trustworthy regulatory authorities whose decisions can be used by other bodies as a basis for their own decisions.

With the WLA list, the WHO aims to ensure that only safe, effective, and high-quality medical products are on the market worldwide.

The members of the Technical Advisory Group for WHO-Listed Authorities (TAG-WLA) met for the first time on 11 and 12 September 2023 at WHO headquarters in Geneva and unanimously recommended the listing of Swissmedic, HSA and MFDS.


Source:

WHO: Statement

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:

How is a QRM process initiated?

How is a QRM process initiated?

You can view the answer here:
Read more
EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

EDQM: 9 Virtual Training Modules on Ph. Eur. and CEPs

The EDQM has introduced a modular training programme covering chemically defined active substances and medicinal products. It will take place between 1 and 12 December 2025.
Read more
FDA: Updated Pre-RFD Guidance for Combination Products

FDA: Updated Pre-RFD Guidance for Combination Products

The U.S. FDA has released an updated final guidance on preparing a Pre-Request for Designation (Pre-RFD), replacing the previous 2018 version. The revised document provides new recommendations for interacting with the Office of Combination Products (OCP) and clarifies expectations for Pre-RFD submissions.
Read more
 Data Integrity and Data Governance

Data Integrity and Data Governance

Data integrity is a key element in the pharmaceutical quality assurance system which has gained importance in recent years, especially from the viewpoint of the authorities. In GxP-regulated companies, managers are responsible for identifying and minimising risks to data integrity (“data governance”).

Read more
EMA Clarifies “Novel or Complex Manufacturing Process” Definition

EMA Clarifies “Novel or Complex Manufacturing Process” Definition

In its Quality of Medicines Q&A – Part 1, the EMA has clarified how “novel or complex manufacturing processes” should be interpreted for variation categories Q.II.b.1 (new/replacement finished product manufacturing site) and Q.II.b.4 (change in batch size).
Read more
EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines

EU: Environment Committee Comments on EU Regulation Regarding Critical Medicines

The Environment Committee of the European Parliament has issued its opinion on the proposed EU Regulation to strengthen the availability of critical medicines. Key recommendations include fast-track permitting, simplified environmental assessments, and support for strategic manufacturing projects to boost EU production capacity.
Read more
Previous
Next