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News about GMP/cGMP

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: Refinded 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 Nitrsosamines 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WHO: Draft Guidance on Continuous Manufacturing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.

ANVISA: Relying on International Evaluation Reports
06.12.2024

The Brazilian health regulatory authority, ANVISA, has decided to consider evaluation reports from international regulatory bodies in their decision-making process.

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.

ICH: Q13 Video Training Material Modules 1–12
29.11.2024

The ICH has published the ICH Q13 IWG "Continuous Manufacturing of Drug Substances and Drug Products" Modules 1–12 video training material.

EDQM: General Chapter „Elemental Impurities (G-07)“ Harmonised
29.11.2024

The Pharmacopoeial Discussion Group (PDG) signed off on the harmonised general chapter “Elemental Impurities (G-07)” on 19 June 2024. The PDG, which includes the European Pharmacopoeia (Ph. Eur.), Indian Pharmacopoeia Commission (IPC), Japanese Pharmacopoeia (JP), and United States Pharmacopeia (USP), worked on this chapter to align elemental impurity requirements across regions based on the ICH Q3D Guideline.

EC: Q&As on Gradual Roll Out of EUDAMED
22.11.2024

The European Commission (EC) has published a Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.

EMA: New Q&A on Supply Chain Traceability
22.11.2024

The EMA has revised the Q&As on good manufacturing and distribution practices (GMPs/GDPs). A new question and answer on the documentation of supply chain traceability has been added to the section about EU GMP Guide Annex 16 certification by a qualified person and batch release.

Blog-News aus Europa
15.11.2024

The European Directorate for the Quality of Medicines & HealthCare (EDQM) will launch the online-only European Pharmacopoeia (Ph. Eur.) in June 2025, transitioning to a more environmentally friendly format. The new platform will enhance user experience with a modern interface and improved search tools.

ICH: Assembly Meeting 2024
15.11.2024

The International Council for Harmonisation (ICH) held its Assembly Meeting in Montréal, Canada on November 5-6, 2024.

Blog-News aus Europa
08.11.2024

The Analysis and Control Laboratories Department of the Turkish Medicines and Medical Devices Agency has become a full member of the General European OMCL Network (GEON), co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

PMDA Opens Office in the USA
08.11.2024

The PMDA has established an office in Washington, D.C. This is the PMDA's second overseas office, following the establishment of the Asia office in Thailand in July.

ICH: Q9(R1) Updated Training Materials
04.11.2024

ICH has published the updated training materials related to ICH Q9(R1) Quality Risk Management (QRM). These materials, include a Q9(R1) Introduction Presentation replacing 5 presentations in the current ICH Q9 Briefing Pack and updated ICH Q8/Q9/Q10 Training Material which replaces 12 presentations developed in 2006-2010.

EC: Q&A Information on Interruption or Discontinuation of Supply of Medical Devices
04.11.2024

The European Commission has published a Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR).

EU: Parliament Votes to Revise MDR and IVDR
25.10.2024

On 23 October, the European Parliament has adopted a resolution to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) to address ongoing implementation challenges and support patient access to essential medical devices by 2025.

EC: Guidance on Qualification of IVDs
18.10.2024

The European Commission (EC) Medical Device Coordination Group (MDCG) has published guidance on qualification of in vitro diagnostic medical devices (IVDs) (MDCG 2024-11). The guidance determines which products fall under the scope of Regulation (EU) 2017/746 (IVDR) as IVD.

ICH: Report of 2024 Implementation Survey
11.10.2024

The ICH has published the 2024 Implementation Survey Report. It contains the results of a study aimed to monitor the adequacy of implementation and adherence to ICH Guidelines by regulatory authorities – continuing the assessment initiated in 2019 and repeated in 2021.

EMA: Draft Guideline on Elemental Impurities in Veterinary Medicines
04.10.2024

The EMA has published for consultation the draft guideline on risk management requirements for elemental impurities in veterinary medicinal products (VMPs). As the Ph. Eur. General Monograph 2619 on pharmaceutical preparations applies to all VMPs, risk management of elemental impurities in all VMPs in the EU market is expected.

Swissmedic: SwissGMDP Database Launched
27.09.2024

Swissmedic has launched the SwissGMDP database, which gives public access to GMP and GDP certificates of all authorised Swiss pharmaceutical companies.

Anvisa: Dashboard with List of APIs Awaiting Registration
27.09.2024

Brasil‘s Anvisa has launched a new tool, a dashboard, which allows you to consult the list of active ingredients in medicinal products for which registration applications are being assessed by the agency.

EMA: New Q&As for Co-processed Excipients Used in Solid Oral Dosage Forms
20.09.2024

The EMA has published for consultation new Q&As for co-processed excipients (CoPEs) used in solid oral dosage forms. The document outlines the quality requirements for CoPEs used in solid oral dosage forms in both human and veterinary medicinal products.

MHRA: Guidance for Manufacturers Following Revised Brexit Deal
20.09.2024

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued new guidance for wholesalers and manufacturers in response to the Windsor Framework, which updated the terms of Brexit.

EMA: Revision 6 of the Appendix 1 on AIs for N-Nitrosamines
13.09.2024

EMA published the revision 6 of the Appendix 1 (“Acceptable intakes (AIs) established for N-nitrosamines”) of the EMA Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products (EMA/409815/2020 Rev.21).

FDA: Control of Nitrosamine Impurities
13.09.2024

The FDA published the second revision to the industry guidance on "Control of Nitrosamine Impurities in Human Drugs".

PDA: New Publications and Formation of the D/A/CH Chapter
13.09.2024

During the press conference of the PDA/FDA Joint Regulatory Conference 2024, PDA (Parenteral Drug Association) announced interesting new publications and the formation of the new D/A/CH Chapter to support local members.

EMA: Guiding Principles on LLMs, a Category of Generative AI
11.09.2024

On 5 September 2024 the EMA and the Heads of Medicine Agencies HMA, published guiding principles that set how EU medicine regulators can use large language models (LLMs), a form of generative AI, focusing on text generation in regulatory science and for regulatory activities. The 10-page document provides high-level recommendations to facilitate LLMs' safe, responsible, and effective use, being of interest to anyone who uses or would like to use such AI models in the future.

Swissmedic: Update of Responsible Person Requirements
04.09.2024

Swissmedic published an updated version of Technical Interpretation 17: Responsible Person: requirements on 26 August 2024. The document outlines the Swiss Inspectorate’s understanding of an RP in accordance with the Medicinal Products Licensing Ordinance (MPLO). It can also serve as a reference for companies to assess whether an individual meets the criteria for applying to Swissmedic to act as an RP.

EMA: Revision of Guideline on Environmental Risk Assessment (ERA) enters into force
28.08.2024

This guideline is an essential reading for all regulatory professionals involved in preparing MAAs. It describes the revised requirements for assessing the potential environmental risks of human medicinal products. The guideline was adopted on 15 February 2024 and will enter into force on 1 September 2024. The changes and extended requirements for environmental risk assessment will be mandatory for all pharmaceutical companies placing their medicines on the EU market.

DRA Pakistan: Rapid Alert on Falsified Propylene Glycol
27.08.2024

The Drug Regulatory Authority of Pakistan (DRAP) issued a Rapid Alert on 22 August 2024 regarding counterfeit batches of Propylene Glycol. The batches are tagged with Dow Chemical labels, and some are declared to be from 'Dow Europe GmbH, Made in Germany'.

CDSCO: Indian Agency Drafts Revised GDP Guidelines
21.08.2024

The Central Drugs Standard Control Organization (CDSCO), the Ministry of Health, and the Government of India have released a 25-page document Draft Guidelines on GDP for Pharmaceutical Products. The guidelines have been developed following WHO TRS 1025 Annex 7: Good Storage and Distribution Practices for Medical Products, with a broader focus on pharmaceutical product storage.

Swissmedic: Updated Information on Non-Standardized Medicinal Products
16.08.2024

Swissmedic has issued an update regarding non-standardized medicinal products, revising an information sheet and the list of products impacted by a specific manufacturing regulation. This product category addresses patient-specific preparations.

Blog-News aus Europa
15.08.2024

The EMA has published an updated Q&A on the impact of MRA between the EU and the US. Since last year, the US has confirmed the capability of 4 additional EU Member States for veterinary product inspections.

TGA: Australia Consults on Partially Harmonising with EU MDR/IVDR
13.08.2024

The Therapeutic Goods Administration (TGA) has initiated a consultation phase to harmonise the basic principles for medical devices in Australia with the EU Medical Device Regulations. A comparison of the two regulatory systems revealed that the EU MDR and IVDR regulations impose additional safety and performance requirements, e.g. for clinical evidence or the information to be provided for medical devices. The keywords here are risk minimisation, risk management systems, and measures to reduce risks due to user error.

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