26th Global GMP & Regulatory API Conference from 25-26 October 2023

APIC/CEFIC in cooperation with Concept Heidelberg have organized the Global GMP & Regulatory API Conference for the 26th time. It was conducted from 25-26 October 2023 once again as a Hybrid Conference - on-site in Berlin and streamed live online.

The event with more than 20 speakers from authorities, industry initiatives and industry received an outstanding rating by the participants from more than 25 countries. Authority representatives included:

  • Alex Viehmann, US FDA, USA
  • Thaila Coradassi de Almeida, ANVISA, Brazil
  • Nimet Filiz, EDQM, France
  • Ibrahim H. Mujammami, SFDA, Saudi Arabia
  • Hikage Shunin, PMDA, Japan

Alex Viehmann, US FDA, USA, gave an overview about ICH Q9(R1) – doing its presentation remotely. He described the milestones and progresses of the revision of ICH Q9 and showed the references to ICH Q10. In total, he mentioned four cross-references, as an example, one of these is based in the new section called “The role of Quality Risk Management in addressing Product Availability Risks” and is related to “oversight of outsourced activities and suppliers”.

Thaila Coradassi de Almeida, ANVISA, Brazil, provided an update from the ANVISA inspectorate. She summarized ANVISA’s approach during the Covid-19 pandemic, the most common non-conformities during GMP inspections, the scenario of ANVISA’s GMP certification programme for foreign APIs and showed an overview of the regulatory requirements.

Nimet Filiz, EDQM, France, presented the current initiatives of EDQM and its role in protecting public health. She started with the novelties of the European Pharmacopoeia (Ph. Eur.) including the topics Nitrosamines, the new pyrogenicity and excipients strategies and the medicinal product monographs in general.  EDQM’s activities with regard to the CEP 2.0 project were the second part of her lecture showing the timelines of the project and the changes compared to the former system. Finally, Nimet explained the new requirements for the content of the CEP dossier and provided an overview of the next steps after the implementation of the CEP 2.0.

Ibrahim H. Mujammami, SFDA, Saudi Arabia, explained the role of SFDA in quality of APIs, challenges of APIs in the Middle East and most common quality aspects. Additionally, he presented four case studies and showed SFDA’s approaches for mitigation of quality issues.

Hikage Shunin from PMDA, Japan, provided an overview about PMDA’s activities and highlighted that the “application form (AF) is a legally binding document in Japan”. He also stated that a “post-approval regulatory action is required, if a marketing authorization holder changes the description in the application form” and that “regarding post-approval change of AF, scientific justification of a change must be adequately explained in CTD”.

Further speakers from industry informed about hot GMP and regulatory topics with regard to APIs – such as the development of second generation APIs, API stability studies, the new APIC Guide on best practices for managing suppliers to API manufacturers, ICH M7, complexities of sterile injectable submissions, the API Guide on Quality Agreements, the revision of the ICH M4Q guideline, digitalization in the API industry and many more received high attention.

SAVE THE DATE! The 27th Global GMP & Regulatory API Conference will take place from 23 - 24 October 2024 in Vienna, Austria. Also, this year, the conference will be complemented by a Pre-Conference Session (on 22nd of October 2024) and will be once again conducted as a hybrid event – on-site in Vienna and online! High-ranking representatives from international drug authorities and industry will report on current developments in the quality and approval of APIs in Europe and non-European countries.


Here are some pictures taken at the Conference. Click on the pictures to enlarge them: