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.
07.02.2025
The European Commission (EC) launched a Biotech and Biomanufacturing Hub.
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.
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.
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.
31.01.2025
The EMA has published for consultation a reflection paper on the qualification of non-mutagenic impurities (NMI).
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.
17.01.2025
The FDA has published Considerations for Complying with 21 CFR 211.110 for comment.
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.
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.
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.
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.
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).
20.12.2024
The EMA has published two new GDP Q&As for wholesale distributors and brokers on suspicious offers.
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.
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.
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.
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).
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.
06.12.2024
The Brazilian health regulatory authority, ANVISA, has decided to consider evaluation reports from international regulatory bodies in their decision-making process.
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.
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.
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.
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.
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.
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.
15.11.2024
The International Council for Harmonisation (ICH) held its Assembly Meeting in Montréal, Canada on November 5-6, 2024.
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).
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.
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.
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).
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.
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.
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.
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.
27.09.2024
Swissmedic has launched the SwissGMDP database, which gives public access to GMP and GDP certificates of all authorised Swiss pharmaceutical companies.
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.
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.
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.
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).
13.09.2024
The FDA published the second revision to the industry guidance on "Control of Nitrosamine Impurities in Human Drugs".
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.
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.
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.
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.
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'.
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.
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.
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.
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.