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News about GMP/cGMP

MedTech: Call for Structural Reform of MDR and IVDR

MedTech Europe, along with 34 national associations, published an open letter to EU Health Commissioner Stella Kyriakides on 14 September 2023.

EMA: Q&A on Biological Medicinal Products

The EMA has published 14 questions and answers for biological products on its website. The CHMP Biologics Working Party developed the page that provides their agreed positions on issues that typically arise from discussions or correspondence during assessment procedures of biological human medicinal products.

WHO: Draft on Good Practices for Pharmaceutical Quality Control Laboratories

The WHO has recently published a draft document that will be of interest to all GMP practitioners in the field of pharmaceutical quality control laboratories: WHO good practices for pharmaceutical quality control laboratories. It provides recommendations for a Quality Management System (QMS) within which analyses of pharmaceutical products should be performed by quality control laboratories. The aim is to ensure accurate and reliable analytical results.

Swissmedic: Swiss GMDP database in early 2024

According to Swissmedic, the independent SwissGMDP database will be launched in the first quarter of 2024. The database will be maintained similar to the European EudraGMDP database of the EMA. The GMP or GDP certificates of every company in Switzerland that has a valid Swissmedic operating licence will be listed. Contrary to the EudraGMDP, the SwissGMDP certificates contain all approved activities, i.e. the GDP activities and Switzerland-specific GMP activities of the Swiss companies will also be listed in the certificates.

Swissmedic: GMP/GDP inspections accreditation for ATMPs

On 9 August 2023, Swissmedic announced its accreditation for GMP/GDP inspections in the field of ATMPs (Advanced Therapy Medicinal Products). Previously, the authority's competence confirmation was limited to medicinal products.

EMA: Q&A on Nitrosamines Updated to Rev. 17

To a new one! The EMA Q&A on nitrosamine impurities has been updated again after only three weeks and is now available as Revision 17 corr. The update concerns Q&As 20, 21 and 22 and a correction of the table including the potency score calculation in example 4 for N-nitroso-l-nebivolol. It had been omitted in the previously revised version 17 and has now been re-introduced.

MHRA: Independent Regulation of CE Marking of Medical Devices

On 1 August 2023, the UK government published a statement on the indefinite extension of CE marking recognition beyond 2024. MHRA clarifies: This extension does not apply to medical devices and in vitro diagnostic medical devices.

FDA: Guidance on Substance-related Nitrosamine Risks

This month the US FDA issued a 28-page new guidance for immediate implementation, Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs). It provides drug manufacturers and applicants with a framework for a risk-based safety assessment of NDSRIs that could be present in approved and marketed drug products, as well as products under review by the FDA. Ways to predict the mutagenic and carcinogenic risk of NDSRIs and acceptable intake (AI) limits are outlined.

PIC/S: Revision of GMP Guide includes new EU Annex 1

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) has again revised its GMP Guide. Changes have been made to include the new EU Annex 1 on Sterile Manufacturing of Medicinal Products, which enters into force on Friday, 25 August 2023. From this same date, the PIC/S GMP Guide will also be valid.

MHRA: Guidance on Labelling/Packaging of Medicinal Products

The UK MHRA has released guidance on the labelling and packaging of medicinal products following the Windsor Framework. It introduces a “UK Only” label and the take over of the MHRA to approve and license medicines across the UK. Furthermore, the application of the EU Falsified Medicines Directive (FMD) in Northern Ireland will no longer apply. The Windsor Framework covers the supply of medicines into Northern Ireland and will replace the current Brexit conditions.

Swissmedic: Mutual Recognition Agreement with US FDA in Force

The Mutual Recognition Agreement between Switzerland and the USA signed in January entered into force on 27 July 2023. As already reported, the MRA allows the FDA and the Swissmedic to share and use each other's GMP inspectional findings regarding medicinal products.

EC: Updated Q&A on MDR and IVDR

The European Commission updated the Q&A document on the new transitional provisions for certain medical devices and in vitro medical devices with five additional questions on 18 July 2023.

EMA: Q&A on Remote Batch Certification and QP Residency

The European Medicines Agency (EMA) has published four new questions and answers around Remote Batch Certification/Confirmation of a Qualified Person (QP). One Q&A deals with the residence specification for a QP. They apply to EU/EEA QP certification or QP confirmation, as described in EU GMP, and specifically in Annex 16. It applies to the manufacture and importation of human and veterinary medicinal products and investigational medicinal products.

EMA: Update Q&A "Centralised Procedures"

In late June 2023, the European Medicines Agency updated two Q&A documents on centralised marketing authorization procedures. With this, EMA provides scientific and regulatory advice to pharmaceutical companies on the regulatory process for the European drug approval. Q&As relevant before, during, and after the approval of medicines for the European market have been updated or newly added.

EMA: Expiration of Extraordinary COVID-19 Regulatory Flexibility

On 6 July 2023, the European Medicines Agency (EMA), the European Commission (EC) and the Heads of Medicines Agencies (HMA) announced that they were phasing out the extraordinary regulatory flexibilities for medicines that were effective during the COVID-19 pandemic.

EMA: Q&A on Nitrosamines Updated

The EMA has updated its Q&A document on N-nitrosamines as of 7 July 2023. Revision 16 comes with an amendment to Q&A 10 on the limits that apply for N-nitrosamines in medicinal products. Introduced are the Carcinogenic Potency Categorization Approach (CPCA) and the enhanced Ames test (EAT) for establishing acceptable intakes (AIs) for N-nitrosamines.

FDA/CDER: Revised MAPP on cGMP Surveillance Inspections

The US FDA’s CDER revised the Manual of Policies and Procedures (MAPP) on managing surveillance inspections based on its Site Selection Model. The CDER staff uses this model to prioritise manufacturing sites for national and international routine quality-related cGMP surveillance inspections.

Swissmedic: Specialist Group for Nitrosamine Issues

On 1 July 2023, the new "Nitrosamines Specialist Group" of the Swiss regulatory agency Swissmedic started its work, as announced in May. The group is divided into a coordination office and a centre of expertise for all issues regarding nitrosamines.

ICH: Press Release ICH-Assembly Meeting

The ICH published a press release on June 20, regarding a face-to-face meeting on June 12 and 13, 2023, in Vancouver, Canada. Meetings of 14 working groups, the ICH Management Committee and the MedDRA Management Committee were also held during that time.

TGA: Regulatory requirements for medical devices

The Australian Therapeutic Goods Administration (TGA) has opened a consultation on 16 June 2023 on the risk classification of medical devices containing certain animal, microbial or recombinant materials.

MHRA: New Recognition Routes with Seven Regulatory Partners

The MHRA is further extending its regulatory network. A new regulatory recognition framework for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore, and the United States. It should be in place by the first quarter of 2024.

EC: Template for Notified Bodies

On 24 May 2023, the European Commission provided a downloadable template that notified bodies can use under Regulation (EU) 2023/607.

EMA: EU – US Mutual Recognition Agreement for Veterinary Medicines Inspections

The mutual recognition of inspections of certain veterinary medicines between the European Union and the United States has reached a significant milestone: On 31 May 2023, the US FDA recognised the capability of 16 EU Member States to carry out GMP inspections for certain veterinary products at a level equal to the US. At the same time, the EU also recognised the FDA as an equivalent authority for GMP inspections of sites manufacturing veterinary medicines.

Now available: Chapter on Contamination Control Strategy in the GMP Compliance Adviser

In the context of the revised Annex 1 (we reported), the Contamination Control Strategy (CCS) is currently an issue everyone is talking about. This concept must be implemented by 25 August 2023 – when Annex 1 comes into force.

EDQM: 21st Edition of the Blood Guide Published

The European Directorate for the Quality of Medicines & HealthCare (EDQM) published the 21st edition of the Guideline for the Preparation, Use, and Quality Assurance of Blood Components earlier this month. As a compendium of widely accepted, harmonised European technical standards the guide should provide safety, efficacy, and quality requirements for the preparation, use, and quality control of blood components in Europe and beyond.

UK and Switzerland Negotiate New Trade Arrangement

According to a press release from the UK government Switzerland and the United Kingdom have started negotiations on a modern and free trade arrangement (FTA) this month.

EMA: Annual Report 2022 Published and Workplan for GMDP Updated

As part of the recent publication of EMA's Annual Report 2022, the 3-year work plan 2021-2023 has also been updated. The 13-page work plan has been developed with a main focus on the network strategy and the scientific regulatory strategy (RSS). The security and resilience of the supply chain is of particular importance.

EMA: Guidance for Industry to Prevent Medicine Shortages

On 17 May 2023, EMA published recommendations for industry on the good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact. The 14-page guidance describes the various stakeholders involved in the medicine supply chain and their responsibilities and roles in the prevention and management of medicine shortages. It provides ten recommendations for marketing authorisation holders, wholesalers, distributors, and manufacturers to minimise the occurrence of medicine shortages and their impact.

EU: Proposal on Reform of  Pharmaceutical Legislation

On 26 April 2023, the European Commission published a 182-page proposal for the reform of the EU's pharmaceutical legislation and a 184-page proposal for the repeal of Directives 2001/83/EC and 2009/35/EC with a 103-page Annex. The proposal should pave the way for the biggest reform in more than 20 years and aims to reshape the regulation of the pharmaceutical sector.

Swissmedic: Guidance on GMP-Compliance by Foreign Manufacturers and RP Declaration

The Swissmedic Guideline on GMP-Compliance by Foreign Manufacturers was published on 1.5.2023 as version 3.0. It is addressed to the holders of marketing authorisations for medicinal products from abroad or from Switzerland if these medicinal products contain active substances from foreign manufacturers.

EMA: Multi-factor Authentication for CTIS Mandatory by June

From 1 June 2023 multi-factor authentication (MFA) will be introduced for user login to CTIS (Clinical Trials Information System) for both sponsors and Member States. This should significantly increase user account security.

WHO: Draft on Revised GMP for Excipients in Pharmaceutical Products

This week the WHO published a draft guideline on GMP for excipients used in pharmaceutical products. With the original guideline published in 1999, a revision was overdue. Excipients play an essential role in pharmaceutical dosage forms and their impact on the quality of the finished product is considerable. The guideline is addressed to excipient manufacturers and pharmaceutical manufacturers.

EMA: GCP-Guideline on Computerised Systems and Data Integrity

Last month, the EMA published the final guideline on computerised systems and data integrity in clinical trials, which will enter into force on 10 September 2023. Clinical trials are increasingly using computerised systems for data collection, which come with progressively more complex user surfaces.

EMA: Q&A on Nitrosamines Updated

The European Medicines Agency EMA updated its Q&A on nitrosamines on 30 March 2023. The update amends Q&A 22 referring to the approach to control  the presence of nitrosamines exceeding the AI during CAPA implementation. It is now indicated that no variation should be submitted to implement temporary above AI (acceptable intake) limits in specifications.

Swissmedic: Equivalence with New EU MDR/IVDR Timelines

The Swiss Federal Council intends to grant an extended period for the certification of medical devices in accordance with the extension of the corresponding EU regulation (we reported). This will require an amendment of the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO). The revision of the two ordinances is planned for autumn 2023.

ICH: Publication of the Introductory Presentation on ICH Q9 (R1)

The ICH published a 29-page presentation on the revision of ICH Q9 on 14 March 2023. The guideline on quality risk management was published in January 2023 (we reported) and will come into force in July 2023.

EU: Q&A on extended MDR transition

The European Commission has released a 10-page Q&A document on the practical aspects of the new transitional provisions for certain medical devices and iv-medical devices. These were laid down in the Regulation (EU) 2023/607, which was published on 15 March 2023 (we reported).

EU MDR/IVDR: New Transitional Provisions Enter into Force

The 6-page amending Regulations (EU) 2023/607 with new transitional provisions for certain medical devices and in vitro diagnostic medical devices was published in the Official Journal of the European Union on 20 March 2023. It entered into force upon publication. This is intended to alleviate supply shortages of important medical devices (we reported). The regulation is binding in its entirety and directly applicable in all member states.

FDA: Definition Guidance on Drug Safety in the Supply Chain

On 16 March 2023, the FDA issued its final guidance on detailed definitions around "suspect products" and "illegitimate products".

EU-MDR/IVDR: Reassessment of Notified Bodies Only Every 5 Years

On 8 March 2023, the European Commission published Delegated Regulations (EU) 2023/502 and 2023/503 to extend the reassessment period for notified bodies under MDR/IVDR to five years. The new time frame has already come into force.

EC: General Political Agreement with UK on Northern Ireland Protocol

The Northern Ireland question was one of the trickiest open issues in the Brexit negotiations. A general political agreement has now been reached with the so-called "Windsor Framework": The European Commission and the government of the United Kingdom have put together a comprehensive package of solutions to reconcile the movement of goods to Northern Ireland while ensuring effective protective measures for the EU's internal market. The Windsor Framework is to replace the previous Northern Ireland Protocol in the future. The legally binding adoption is pending.

FDA: ICH Q13 Guideline and Artificial Intelligence in Drug Manufacturing

On 1 March 2023, the final ICH Guideline Q13 on continuous manufacturing (CM) of active pharmaceutical ingredients and drug products was published by the FDA. In addition to the guidance, the agency also issued a discussion paper on AI for stakeholders' comments. With these publications, the FDA aims to facilitate the adoption of advanced manufacturing technologies for the pharmaceutical industry.

EU-MDR: European Parliament Votes in Favour of New Transition Periods

On 16 February 2023, the European Parliament voted positively to extend the deadline for the certification of medical devices under the EU Medical Devices Regulation (MDR). In January, the deadline extension was proposed by the European Commission to prevent massive supply shortages. Not enough Notified Bodies are available for the recertification of many medical devices, as a requirement of the MDR.

EMA: Q&A for Cannabis-Derived Medicinal Products

The EMA has published a question and answer document on the regulatory requirements for the authorisation of Cannabis-derived medicinal products in the EU and the work of the Committee for Herbal Medicinal Products (HMPC) in relation to medicinal plant monographs. This was considered useful as those involved in the production of Cannabis products often have little experience of the EU regulatory system for medicinal products.

Swissmedic: Validity of GMP Certificates

Swissmedic announced on 23 January that companies with a valid manufacturing licence for the manufacture of medicinal products can apply for a GMP certificate. The certificates do not contain a validity date, but the date of the GMP inspection.

EMA: ICH Guideline Q9 (R1) on Quality Risk Management – Step 5

On February 6th, 2023, the European Medicines Agency (EMA) published the first revision of the guideline "ICH Guideline Q9 (R1) on Quality Risk Management (QRM) Step 5".

The 27-page document includes "principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.“

PIC/S: Publication of New GDP Guidance Documents

PIC/S has published the following two guidance documents for GDP inspectors: an ‘Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain’ (PI 044-1) and a ‘Questions & Answers (Q&A) document regarding the PIC/S GDP Guide’ (PS/INF 22/2017).

EMA: Use of CTIS mandatory in the EU

As we already reported in December 2022, the use of the Clinical Trials Information System (CTIS) is now obligatory in the EU.

ICH: Final Publication of Revised ICH Q9 Guideline

The International Council for Harmonisation (ICH) published a revised version of its Q9 guideline on 20 January, updating the original guideline, which is now 18 years old.

USA: Transition to ISO 13485 is getting closer

The US government's Office of Information and Regulatory Affairs has issued a timeline for harmonizing, or converting, the 21 CFR 820 with the European ISO 13485 for medical devices.

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