SwissGMDP database

One click closer to transparency: Swissmedic announces the SwissGMDP database

Dr. Sandra Ragaz-Fumia
Partner I Leader Pharma & Life Science – International Indirect Tax & ReguIatory

Dominik Hofstetter
Pharma & Life Science Regulatory, PwC Switzerland

Swissmedic, the Swiss regulatory authority for medicinal products, is introducing a new database that will provide free and easy access to the GMP and GDP certificates of all companies in Switzerland with a valid establishment licence issued by Swissmedic. This development will increase the transparency and security of the medicinal product distribution chain and the active substance supply chain in Switzerland.

Background

Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are quality standards that ensure the safety, quality and efficacy of medicinal products and active substances throughout their lifecycle. Companies that manufacture, import, export, distribute or store medicinal products or active substances in Switzerland need to obtain a respective licence in accordance with their planned activity from Swissmedic and comply with the GMP and/or GDP requirements. Swissmedic issues GMP and GDP certificates to these companies after conducting inspections and verifying their compliance. These certificates are valid for a limited period of time and need to be renewed regularly.

Until now, Swissmedic has issued GMP and GDP certificates in paper form for a fee of CHF 200 (which excludes additional fees for supplemental documents).^[1] The certificates have been sent to the companies or to the authorities of other countries where the companies operate or export their products. However, this process has been time consuming, costly and prone to errors or fraud. Moreover, the certificates have not been publicly available so far.

^{_{[1] Ordinance of the Swiss Agency for Therapeutic Products on its Fees (Fee Ordinance-Swissmedic) Annex 1, VI. Fees for Certificates], SR 812.214.5}}

What the SwissGMDP database means for companies, authorities and consumers

Swissmedic is bringing a SwissGMDP database into operation, similar to the EMA’s EudraGMDP database. It will list the GMP and GDP certificates of all companies in Switzerland with a valid establishment licence issued by Swissmedic. The certificates in the SwissGMDP database will include all authorised activities, (unlike EudraGMDP, the GDP activities and Switzerland-specific GMP activities of Swiss companies will also be listed in the certificates).

All companies, authorities and individuals can easily view a company’s GMP/GDP status using the SwissGMDP database.

Furthermore, SwissGMDP enables a query of all licence holders with a valid licence including their sites and licensed operations and will replace the previous table of establishment licence holders. ^[2] To maintain the SwissGMDP database, fees will be charged solely for each request or inspection-driven update of GMP/GDP-related data.

^{_{[2] Swissmedic, ‘Establishment licences issued under the new legislation’}}

The benefits and drawbacks of the SwissGMDP database for pharma companies and stakeholders

The SwissGMDP database will have several benefits for the pharma industry, the regulatory authorities and the public, such as:

Improve the transparency and security of the medicinal product distribution chain and the active substance supply chain by making it easier to check legitimate players and to identify counterfeit or falsified products.
Reduce the administrative burden and costs for the companies and Swissmedic.
Facilitate the international trade and cooperation of Swiss companies, as the certificates will be recognised and accepted by other countries and authorities, especially in the European Union, where the EudraGMDP database is widely used.
Enhance the quality and compliance of Swiss companies, as they will have to maintain their GMP and GDP standards and to report any changes or deviations to Swissmedic in a timely manner.
Furthermore, SwissGMDP provides access to GDP certificates of companies that only have GDP activities on their licence.

The SwissGMDP database will also have some drawbacks or challenges, such as:

The risk of data breaches or misuse of the database by unauthorised or malicious parties, which could compromise the confidentiality or integrity of the information.
The potential for discrepancies or conflicts between the SwissGMDP database and other databases or sources of information, such as the EudraGMDP database, which could create confusion or uncertainty.
With heightened transparency, pharmaceutical companies must prioritise data integrity and compliance with local regulations to mitigate unfavourable outcomes.

The countdown to SwissGMDP and how to be prepared

The SwissGMDP database is a significant and positive development for the pharma sector in Switzerland. It will increase the transparency and security of the medicinal product distribution chain and the active substance supply chain, reduce the administrative burden and costs for the companies and Swissmedic, and facilitate the international trade and cooperation of Swiss companies. However, it will also require attentiveness to data integrity and compliance with regulations to ensure a resilient supply chain. The SwissGMDP is expected to be launched on the Swissmedic website in the first quarter of 2024, with the exact date to be announced in the coming months.