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News about GMP/cGMP

Blog-News aus Europa
06.06.2025

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.

FDA: Launch of “Elsa” AI Tool
06.06.2025

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.

Blog-News aus Europa
30.05.2025

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: Amendment to GMP Compliance by Foreign Manufacturers
30.05.2025

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).

ICH: Assembly Meeting 2025
30.05.2025

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: Updated Q&A on Nitrosamines in Human Medicinal Products
26.05.2025

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

EMA: FAQs on the European Shortages Monitoring Platform (ESMP)
16.05.2025

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

EU: 6 New Nitrosamines for Appendix 1
16.05.2025

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: Concept Paper on the Revision of GMP Guide Part IV on ATMPs
09.05.2025

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

FDA: Unannounced Inspections at Foreign Manufacturing Facilities
09.05.2025

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: Requirement for Risk Assessment Relating to Nitrosamines
09.05.2025

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: New Q&A on Third Party Audits in the QP Declaration
02.05.2025

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

WHO: New Technical Report (TRS 1060) Published
25.04.2025

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.

ICH: Revised ICH Q1 Draft for Consultation
21.04.2025

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.

EMA: 2 New Q&As on Third Party Audits of API Suppliers
11.04.2025

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: Draft Reflection Paper on Linking ePI from Medicine Packages
04.04.2025

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.

China: Draft Revision of GMP Annex for Sterile Drugs
04.04.2025

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: Update of the Technical Interpretation for PQR
04.04.2025

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

EMA: GMDP IWG 3-Year Work Plan (2025–2027)
29.03.2025

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.

EMA: Annual Report of the GMDP IWG 2024
28.03.2025

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

ICMRA: Extension of PQKM Collaborative Pilots
23.03.2025

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. 

Blog-News aus Europa
14.03.2025

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.

IPEC: Updated Position Paper on Third Party Audits
10.03.2025

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.

EMA: Pilots for Post-Authorisation Changes
10.03.2025

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.

EMA: Nitrosamine Impurities – New: Champix Section
03.03.2025

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

EMA: Updated Q&As for Biological Medicinal Products
03.03.2025

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.

EU: 11 New Nitrosamines for Appendix 1
21.02.2025

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: Portal Update
21.02.2025

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.

India: Deadline Extension for Implementation of Schedule M
21.02.2025

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).

MDCG: Notified Bodies and Use of Previous Assessments
14.02.2025

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.

BfArM: AMIce Public Part Becomes Completely Free of Charge
07.02.2025

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.

Blog-News aus Europa
07.02.2025

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

Swissmedic: Refined Interpretation of the MRA with Canada
07.02.2025

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: 3 new Q&As on Diethylene Glycol (DEG) and Ethylene Glycol (EG)
07.02.2025

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.

EMA: Appendix 1 on Nitrosamines Amended
07.02.2025

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

EMA: Draft for Qualification of Non-Mutagenic Impurities
31.01.2025

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

PIC/S: New Partnership with African Union Development Agency
24.01.2025

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.

FDA: Guidance to Ensure Batch Conformity and Drug Product Integrity
17.01.2025

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

WHO: Draft Guidance on Continuous Manufacturing
17.01.2025

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

EMA: Update of Appendix 1 for Nitrosamines
15.01.2025

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

MHRA: Further Guidance on Windsor Framework
10.01.2025

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

Swissmedic: Amendment of the Ordinance on In Vitro Diagnostic Medical Devices (IVDs)
05.01.2025

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: Updated Nitrosamine Limits
05.01.2025

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).

EMA: New Q&As for Wholesale Distributors/Brokers on Suspicious Offers
20.12.2024

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

EMA: Implementation of Electronic Product Information
20.12.2024

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: Guidance on Remote Assessments
19.12.2024

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.

WHO: 2 More African Countries Reached Maturity Level 3
13.12.2024

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.

ICH: Updated Q9(R1) Annex 1 – Q8/Q9/Q10 Questions & Answers
13.12.2024

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).

EMA: Work Plan for the Quality Innovation Group
13.12.2024

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.

Blog-News aus Europa
06.12.2024

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.

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