News about GMP/cGMP

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

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.

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.

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 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).

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

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.

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 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.

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.

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'.

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 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.

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.

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.

The new "swissdamed" medical devices platform has been gradually rolled out since 6 August 2024. The first release of the "Actors" module enables economic operators to register online.

The Australian TGA has introduced temporary 'surveillance inspections' for domestic and overseas manufacturers of medicines, Active Pharmaceutical Ingredients (APIs), biologicals, and blood products.

The EMA published for consultation an update of the guideline on the chemistry of active substances. The need for revision was identified in the report on “Lessons learnt from presence of N-nitrosamine impurities in sartan medicines” (LLE), which makes recommendations to reduce the risk of N-nitrosamines being present in human medicines and to help the European medicines regulatory network to be better prepared to deal with future cases of unexpected impurities.

The EMA has updated its Q&A document on nitrosamine impurities in human medicinal products. In collaboration with the Heads of Medicines Agencies (HMA) responses to six questions were revised. Specifically, EMA updated one answer to reflect its position on the acceptability of the Ames test and another to clarify responsibilities concerning active substance master files and the certification of suitability.

The US Food and Drug Administration (FDA) released a draft guidance detailing how manufacturers should report postapproval manufacturing changes for licensed biosimilar and interchangeable products.

The European Commission has published a new Regulation (2024/1938) providing new rules on standards of quality and safety for substances of human origin (SoHO).

The European Medicines Agency (EMA) updated Appendix 1 (EMA/307633/2024 /Rev. 5) of the Nitrosamine Q&As, listing nitrosamines with established Acceptable Intake (AI) values.

Regulation (EU) 2024/1860 amending the MDR and the IVDR was published in the Official Journal of the EU on 9 July and entered into force immediately.

The Japanese Ministry of Health, Labour and Welfare (MHLW) has published an updated English translation of the Ministerial Order on the Standard of Manufacturing Control and Quality Control for Pharmaceuticals and Quasi-Pharmaceuticals.

The Medical Device Coordination Group (MDCG) has updated its guidance on standardisation for medical devices, including topics such as the European Pharmacopoeia and common specifications.

The European Commission (EC) launched an online public consultation on cooperation with the European Medicines Agency (EMA) under the Health Technology Assessment (HTA) Regulation. The cooperation, which is outlined in a draft implementing act, includes the exchange of information between the Coordination Group on Health Technology Assessment (Member States), the Commission and the EMA.

While the European Pharmacopoeia (Ph. Eur.) already includes parts of the ICH Q3D guideline on elemental impurities in the general chapter on Elemental impurities (5.20), the requirements for extractable elements from plastic containers for pharmaceutical use and closures are legally binding.

EMA releases templates to assist marketing authorisation holders (MAHs) in creating plans to prevent and mitigate shortages. The EMA is urging MAHs in the EU/EEA Area to develop a plan to prevent shortages and minimise the likelihood of shortages for their marketed medicines.

The Medical Device Coordination Group (MDCG) has revised its guidance regarding the designation, re-assessment, and notification of conformity assessment bodies and notified bodies.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has published details of what its members are doing to improve the environmental sustainability of the pharma industry. EFPIA aims to adopt innovative practices that reduce environmental impact, exceeding EU Green Deal targets under the Zero Pollution, Circular Economy, and Climate Action plans.

The International Council for Harmonisation (ICH) held its Assembly on 4-5 June 2024 in Fukuoka, Japan, alongside meetings of 13 Working Groups, the ICH Management Committee, and the MedDRA Management Committee. ICH welcomed new members ANMAT (Argentina) and JFDA (Jordan), expanding to 23 Members and 35 Observers.

The Medical Device Coordination Group (MDCG) issued a second revision to its surveillance guidance for medical devices. The changes align the guidance with EU regulations on transitional provisions for certain medical devices and in vitro diagnostic devices (IVDs).

The Q2(R2)/Q14 EWG developed a new ICH Quality Guideline, ICH Q14, on Analytical Procedure Development, and revised the ICH Q2(R1) Guideline on Validation of Analytical Procedures. The ICH Q2(R2) revised Guideline and the Q14 Guideline reached Step 4 of the ICH process on 1 November 2023. A Step 4 introductory training presentation has now been developed by the Q2(R2)/Q14 Expert Working Group.

The European Commission (EC) has published a new version 21 of its Q&As on safety features for medicinal products for human use. Four new questions have been added.

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has drafted a guideline ‘Content of the dossier for sterile substances’ (PA/PH/CEP (23) 54). The draft document is now available for public consultation until 15 August 2024.

The EMA has published a new revision of the guidance available to applicants, marketing authorisation holders and notified bodies of medical devices. This question-and-answer document provides practical considerations on the implementation of the medical devices and in vitro diagnostic regulations (MDR and IVDR) for combinations of medicinal products and medical devices.

An update of the Appendix 1 (“Acceptable intakes established for N-nitrosamines”) of the 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 has just been published by the EMA.

The GMP/GDP Inspectors Working Group has amended their FAQs on GDP. Two new questions deal with the possibility and conditions for remote activities of the resposible person (RP) for GDP.

The FDA has issued final guidance clarifying "remanufacturing" for reusable medical devices needing maintenace or repair, aiming for consistency and better understanding of federal laws.

In its Q&A section on GMP and GDP, EMA has added questions and answers on additional guidance to Annex 8 on sampling excipients at risk of glycol contamination, emphasising stringent measures for high-risk substances. In seven key questions, EMA highlights the risks of diethylene glycol (DEG) and ethylene glycol (EG) contamination, emphasising the responsibilities of manufacturers and supply chain management.

On 29 April, the Food and Drug Administration (FDA) issued a final rule that will phase out its general enforcement discretion approach for laboratory developed tests (LDTs) over a four-year period.

The WHO has published a new draft guideline on considerations for the prevention and control of nitrosamine contamination in pharmaceutical products. This guideline applies to all manufacturers of excipients, active pharmaceutical ingredients and finished pharmaceutical products.

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

On 18 April, the EMA launched a new draft version of the Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin.

This update brings the document up to date with current standards, incorporates the increased development of indoor growing technologies and also covers best practice and legal interpretations published over the last 10 years.

On 10 April, the EU Parliament approved a legislative package to reform the EU‘s pharmaceutical legislation, with the aim of boosting innovation and improving the accessibility and affordability of medicines. The package, which includes a new directive and a regulation, recieved strong support from Members of the European Parliament (MEPs).

The Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (Ph. Eur.) are launching a joint project to harmonise pharmacopoeial standards for active substances and medicinal products. This initiative aims to reduce the burden on manufacturers by aligning pharmacopoeial standards across different regulatory regions.

On 27 March 2024, Japan's PMDA (Pharmaceuticals and Medical Devices Agency) published an English-language version of its updated recommendations on the quality, safety, and efficacy of biosimilars. The 14-page document, Questions and Answers on Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars, has been updated to reflect the current state of scientific knowledge. The revised sections of the document are indicated and relate to Q&As 9, 10, and 11.

Appendix 3 of the EMA’s Nitrosamine Q&A has been updated. The Appendix deals with the enhanced Ames test conditions for N-nitrosamines.

On 22 March, the German Cannabis Law was passed by the Bundesrat. The law will therefore come into force on 1 April as planned.