News about GMP/cGMP

The European Council has adopted its negotiating position on the major reform of EU pharmaceutical laws, the 'Pharma Package', and is now ready to start talks with the European Parliament.

The U.S. Food and Drug Administration (FDA) has launched Elsa, a generative AI tool aimed at enhancing the productivity of its employees, from scientists to investigators.

The EDQM has released an updated version of the guideline “How to Read a CEP”, offering clear explanations of the information contained in Certificates of Suitability (CEPs) to European Pharmacopoeia monographs.

Swissmedic has updated its guidance on Good Manufacturing Practice (GMP) compliance for foreign manufacturers, clarifying documentation requirements for various application types (e.g., new authorizations, type IA/IB/II changes for human and veterinary medicines).

The International Council for Harmonisation (ICH) held its Assembly meeting on 13–14 May 2025 in Madrid, Spain, alongside 11 Working Groups and prior meetings of the Management and MedDRA Steering Committees.

EMA has updated ist questions and answers for marketing authorisation holders/applicants on nitrosamine impurities in human medicinal products.

EMA has updated its FAQ document on the European Shortages Monitoring Platform (ESMP), addressing six new questions – five related to data submission and reporting. 

Appendix 1 of EMA’s Questions and Answers on nitrosamine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

EMA has published a concept paper on the revision of GMP Guide Part IV on ATMPs for public consultation. 

The U.S. FDA announced its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for American consumers and patients. 

Swissmedic has established the requirement to submit risk assessments relating to nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents.

EMA has published a Q&A on how to reflect third party audit(s) in part C of the QP declaration.

The WHO has released a series of new and updated guidelines related to pharmaceutical manufacturing, testing, and development, published as part of Technical Report Series No. 1060 (TRS 1060). Annexes 2 through 9 address a range of topics, including nitrosamine control, GMP for excipients, bioanalytical methods and blood establishments.

The International Council for Harmonisation (ICH) released an updated draft of its Q1 guideline on "Stability Testing of Drug Substances and Drug Products". The ICH Q1 draft guideline reached Step 2b of the ICH Process on 11 April 2025 and entered the public consultation period. A Step 2 Informational Presentation has also been developed by the Q1 EWG.

The European Medicines Agency (EMA) has updated guidance on GMP and GDP. The EMA has added two questions and answers on the basic requirements for active substances used as starting material in relation to third party audits.

EMA has published a draft reflection paper on linking electronic product information (ePI) from medicine packages. This paper describes components to be put in place to realise an EU-wide solution in which ePI could be easily accessed by citizens wherever they are in Europe, in their preferred language when available.

The Chinese drug authority NMPA has published its long-awaited draft annex to the Chinese GMP for sterile drugs for public review and comment. There is close alignment with the tripartite WHO/EU/PICs GMP Annex that was published in 2022.

Swissmedic has published an updated version of its technical interpretation for a Product Quality Review (I-SMI.TI.14e).

The 3-year work plan for the EU GMDP Inspectors Working Group (IWG) aligns with Network Strategy goals, emphasising supply chain integrity, product quality, enhancing inspector capacities, and the impact of new manufacturing technologies. 10 documents of the GMP Guide will be revised or newly launched.

The EMA's GMDP Inspectors Working Group (GMPD IWG) has published its 2024 annual report.

The International Coalition of Medicines Regulatory Authorities (ICMRA) Pharmaceutical Quality Knowledge Management (PQKM) collaborative pilots have been extended until the end of 2025. ICMRA is actively seeking new applications for collaborative review by multiple global regulators. 

The European Commission (EC) has proposed the Critical Medicines Act to enhance the availability of essential medicines in the EU. The regulation aims to diversify supply chains, boost EU pharmaceutical production, and improve access to critical medicines.

The International Pharmaceutical Excipients Council (IPEC) Federation has released an update of its position paper advocating for independent third party audits and certification programs. The position paper was first published in September 2015.

In collaboration with the World Health Organization (WHO), the European Medicines Agency (EMA) supports a pilot programme that allows pharmaceutical companies to submit EMA-approved post-authorisation changes (i.e. variations) to multiple non-EU national authorities.

In February 2025, EMA's CHMP adopted a positive opinion approving changes to the manufacturing process for Champix, a smoking cessation medicine.

EMA’s Biologics Working Party has updated the question-and-answer document for biological medicinal products, adding information on nitrogen gas for backfilling, container closure systems and prior knowledge.

Appendix 1 of EMA’s Questions and Answers on nitrosmine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

Swissmedic has updated its medicinal products' portal, introducing a new process for ordering GxP certificates and granting direct access to all pre-registered company administrators. However, Swissmedic acknowledged the absence of a new onboarding process for companies or administrators as a known issue.

At the end of December 2023, the Indian Ministry of Health revised the provisions of Schedule M of the Drugs and Cosmetics Act. Schedule M describes good manufacturing practices (GMP) for pharmaceutical products (we reported).

The Medical Device Coordination Group (MDCG) has updated its questions and answers document on requirements relating to notified bodies to explain how notified bodies can use previous assessments to avoid unnecessary duplication of work.

From 13 February, the Federal Institute for Drugs and Medical Devices (BfArM) will offer the public part of the drug information system (AMIce) in its entirety for free research.

The European Commission (EC) launched a Biotech and Biomanufacturing Hub.

Health Canada and Swissmedic agreed to expand the existing approach to include both the recognition of GMP extra-jurisdictional inspection outcomes (inspections outside Switzerland and Canada) as well as active pharmaceutical ingredient and stable medicinal products derived from human blood or human plasma in the operational scope.

EMA has added three new questions to its guidance on good manufacturing practices to address risks of diethylene and ethylene glycol (DEG/EG) contamination in glycerol and other excipients.

Appendix 1 of EMA’s Questions and Answers on nitrosmine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

The EMA has published for consultation a reflection paper on the qualification of non-mutagenic impurities (NMI).

The PIC/S Committee has granted the African Union Development Agency - New Partnership for Africa's Development (AUDA-NEPAD) the status of Associated Partner Organisation.

The FDA has published Considerations for Complying with 21 CFR 211.110 for comment.

The World Health Organization (WHO) has released a draft document titled Points to Consider in Continuous Manufacturing of Pharmaceutical Products for public comment.

Appendix 1 of EMA’s Questions and Answers on nitrosmine impurities has been updated. This appendix contains acceptable intakes (AIs) established for N-nitrosamines.

The MHRA has published supplementary information for international regulators: export of UK medicines and the new Windsor Framework (Northern Ireland) labelling requirements.
 

The amended Ordinance on In Vitro Diagnostic Medical Devices (IvDO) enters into force on 1 January 2025. Switzerland is implementing extended transitional periods in line with the EU Regulation 2024/1860.

FDA’s CDER has updated the recommended acceptable intake (AI) limits for certain hypothetical nitrosamine drug substance-related impurities (NDSRIs) and other identified nitrosamine impurities (Table 1) as well as the recommended interim AI limits for certain nitrosamine impurities for approved or currently marketed products (Table 3).

The EMA has published two new GDP Q&As for wholesale distributors and brokers on suspicious offers.

The EMA has published a pilot report on the creation and testing of electronic product information (ePI) in regulatory procedures. The findings suggest that the EU regulatory system is ready for ePI and can begin phased implementation, though further development is needed, including additional features and IT system integration.

PIC/S has published two guidance documents for inspectors: "Guidance on Remote Assessments" (PI 056-1) and "Aide Memoire on Remote Assessments" (PI 057-1). These documents will enter into force on 1 January 2025.

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.

The ICH has published the updated Q9(R1) Annex 1: Q8/Q9/Q10 Questions & Answers (R5) related to ICH Q9(R1) Quality Risk Management (QRM).

The EMA has published the three-year rolling work plan for the Quality Innovation Group (QIG) for the period 2025-2027. QIG supports the translation of innovative approaches to the design, manufacture and quality control of medicines.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published further guidance for the preparation of dossiers to obtain a Certificate of Suitability (CEP) for a sterile substance.