Inside View

Zofingen/Nantong: Regulatory Affairs – a Significant Step Forward

The proud team with its first API made at Siegfried Nantong.

On-site inspection

A significant step forward for Siegfried Nantong: in January 2018, the site ­received the first API approval by the European Directorate for the Quality of Medicines (EDQM) and the first Good Manufacturing Practices inspection ­approval by People’s Republic of China Jiangsu Food and Drug Administration, and & HealthCare (JSFDA).

Europe: Certificate of Suitability (CEP) granted
The aim of the project was to support commercial production of an API destined for the European market at Nantong with its own regulatory filing. Based on existing filings for the API already manufactured at Zofingen, a “Certificate of Suitability to the Ph. Eur. monograph” (CEP) was applied. Such certificates are recognized in Europe and many other countries around the world in lieu of DMFs. The abbreviated procedure offers the opportunity to get the certificate in just three months, and indeed the certificate was granted at first go without any questions by the competent authority. 

China: Written Confirmation letter granted
It was the first health authority accreditation by four inspectors from the Jiangsu Provincial FDA (JSFDA) during the three-day GMP site inspection since the establishment of the Nantong site in 2013. The successful passing of the inspection without major or critical findings is a significant step forward for the site. It confirms that the Nantong site is working under Good Manufacturing Practices (GMP) and is subject to supervision by the regional authority JSFDA. With the Written Confirmation letter the Siegfried Nantong site has the shipment permission for a specific API into the European Union (EU) as required in EU’s Falsified Medicines Directive 2011/62/EU. 

As required in the EU Directive 2011/62/EU, any commercial human active substances manufactured outside the EU and imported into the EU since July 2013 had to be accompanied by a Written Confirmation from the regulatory authority of the exporting country. The idea behind was to put pressure on regulators outside of EU to supervise the GMP compliance of the manufacturing sites located in their home country.

The procedure with the Written Confirmation letter has to be repeated for each single human API to be imported into the EU. We see the increasingly complex and demanding regulatory environment globally, yet we hope that the international harmonization of GMP regulations will be moving forward. 

Thanks to the excellent global team cooperation we made this first step. We are convinced that the Nantong site will achieve more successful authority accreditations in the future and become a well-established GMP site in the global Siegfried network.

Siegfried Nantong Ships the first API into the European Union
After having received the CEP and the Written Confirmation in January 2018, Siegfried Nantong could ship the first API into the European Union. Siegfried started manufacturing of this API in 2002 in Zofingen and transferred the process in March 2016 to the Nantong site. The process has been successfully validated and 1.2 t of API have been released in September 2017. This has been the first API produced under GMP conditions at the Nantong site. The yield was very good and all customer requirements have been met including the recent post completion audit by the customer. Thanks to an excellent collaboration and great efforts of the teams in Zofingen and Nantong the transfer project has been successfully concluded.