Pharma GMP News of the Week: 25-September-2022

Period: September 18, 2022 to September 24, 2022

PIC/S website published “list of PIC/S Participating Authorities”, 1 October 2022 

Date of news: September 2022

Source: https://picscheme.org/docview/4753

Revised Annex 1 (Manufacture of sterile medicinal products) to guide to good manufacturing practice for medicinal products is published on PIC/S website

Date of news: September 9, 2022

With the exception of point 8.123, which is delayed until 25 August 2024, the amended Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will come into effect on 25 August 2023. The date of implementation corresponds to that of the updated EU Annex 1, which is the same as PIC/S Annex 1. (with some very minor editorial differences).

A lengthy revision process that was jointly led by PIC/S and the EMA Inspectors’ Working Group (IWG) on GMDP in close collaboration with the European Commission (EC) and the World Health Organization comes to an end with the entrance into force (WHO). The EC, EMA, WHO, and PIC/S have worked together in a way that is best in its class.

Source: https://picscheme.org/docview/4737 

India updated its National List of Essential Medicines

Date of news: September 13, 2022

The Union Health Ministry added 34 new drugs and removed 26 from the National List of Essential Medicines (NLEM) list released on Tuesday, according to Union Health Minister Mansukh Mandaviya.

The National Lists of Essential Medicines (NLEM) 2022 include 384 medicines in total. The list now includes 34 new medications, whereas 26 from the prior list have been removed. These drugs have been classified into 27 therapeutic groups.

Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTAxMg==

Swissmedic is harmonising its standards with those in the European environment to address nitrosamine contamination in pharmaceuticals

Date of news: September 14, 2022

Swissmedic wants to align its standards with those of the European community. The EMA has updated its Q&A guide several times after Swissmedic’s publication on nitrosamines on April 16, 2021. Therefore, Swissmedic is likewise upgrading its specifications based on the most recent iteration of this document and integrating significant amendments made public by the EMA.

Questions and answers regarding the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurity in human medical goods for marketing authorization holders and applicants

The implementation will take place in accordance with the legal requirements for therapeutic items. Departures from the EMA’s strategy may be necessary due to the constraints of Swiss healthcare.

Source: https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/potentielle-verunreinigungen-nitrosaminen-update.html 

News from EMA “Biosimilar medicines can be interchanged”

Date of news: September 19, 2022

According to a joint statement from EMA and the Heads of Medicines Agencies (HMA), biosimilar medicines authorised in the European Union (EU) are interchangeable with their reference medicine or with an equivalent biosimilar.

Even while several Member States already utilise biosimilars interchangeably, this shared viewpoint harmonises the EU policy. It provides more clarity for medical practitioners and enables more patients around the EU to receive biological medicines.

Source: https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged 

The suggested improvements to AI laws to enhance human control are welcomed by MedTech Europe

Date of news: September 19, 2022

MedTech Europe applauds the adoption of the opinion by the European Parliament’s Legal Affairs Committee, which conveys a strong message to the European Parliament’s leading Committees for Civil Liberties, Justice and Home Affairs (LIBE) and Internal Market and Consumer Protection (IMCO) on the importance of context-based human oversight, which is especially important in the healthcare sector.

Source: https://www.medtecheurope.org/wp-content/uploads/2022/09/220919-reaction_juri-committee-vote_ai-act.pdf 

Rules regarding the promotion of medications delivered via a different Northern Irish route are clarified by the MHRA

Date of news: September 20, 2022

Holders of valid NIMAR marketing authorizations shall manage the supply of NIMAR products in a manner comparable to those of medicines covered by NIMAR-specific regulations. However, because the medications on the NIMAR list are covered by GB licences, only England, Scotland, and Wales should actively promote them through advertising. 

This does not exclude appropriate exchanges and communications required to keep up the supply of medications. Marketing authorization holders must follow Part 14 of the Human Medicines Regulations 2012 in all other respects and take all reasonable measures to ensure that advertisements do not run in areas where the medicine is not authorised.

Source: https://www.gov.uk/government/publications/the-northern-ireland-mhra-authorised-route-nimar/the-northern-ireland-mhra-authorised-route-nimar#advertising-and-promotions 

FDA published draft guidance on “How To Obtain a Covered Product Authorization”

Date of news: September 21, 2022

According to the website, this draft document will replace the December 2014 draft guidance for industry How to Obtain a Letter from FDA Stating that Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable REMS for RLD. The draft guidance published in December 2014 guidance has been withdrawn.

In accordance with the CREATES Act, this document explains how qualified product developers can request a Covered Product Authorization (CPA) from FDA. The CREATES Act offers eligible product developers a means of gaining access to the product samples they require to satisfy testing and other legal requirements in order to support their applications. To use this pathway, as further explained below, an eligible product developer must first obtain a covered product authorization from the Agency (see 21 U.S.C. 355-2(b)(2)) in order to develop a product that is subject to a Risk Evaluation and Mitigation Strategies (REMS) with elements to assure safe use (ETASU).

Source: How To Obtain a Covered Product Authorization (fda.gov)

FDA published final guidance on “Electronic Submission Template for Medical Device 510(k) Submissions”

Date of news: September 22, 2022

This guideline outlines additional requirements for premarket notice (510(k)) submissions made in an electronic format, a timeline for their formation, and the standards that must be reached in order to be exempted or waived from a statutory requirement. 

This guidance is also meant to act as one of several steps in fulfilling FDA’s goal to create electronic submission templates that will serve as guided submission preparation tools for business, improving consistency in submissions and boosting review process efficiency. 

FDA has set October 1, 2023 as the deadline for when electronic 510(k) filings must be supplied.

Source: Electronic Submission Template for Medical Device 510(k) Submissions – Guidance for Industry and Food and Drug Administration Staff (fda.gov)

MHRA published “The main decision-making, executive and managerial bodies at the Medicines and Healthcare products Regulatory Agency (MHRA)” on its website.

Date of news: September 22, 2022

Source: https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency/about/our-governance 

FDA received feedback in response to its draft guidance on therapeutic equivalence evaluations, Regulatory Focus, 20 July 2022)

Date of news: September 2022

Stakeholders in the generic pharmaceutical industry urged the US Food and Drug Administration (FDA) to drop its plan to require businesses to submit citizen petitions for therapeutic equivalence (TE) evaluations for 505(b)(2) applications, arguing that this procedure will not be effective and will harm companies that make complex generics. Additionally, they asked that the FDA refrain from removing discontinued medications from the Orange Book.

Source: https://www.regulations.gov/document/FDA-2022-D-0528-0002/comment 

FDA published draft guidance on “Ethical Considerations for Clinical Investigations of Medical Products Involving Children”

Date of news: September 23, 2022

The FDA’s current position on ethical issues for pediatric clinical trials of medicinal goods is described in this document.

For information on the safety and efficacy of medications, biological products, and medical devices in children as well as to safeguard children from the dangers associated with exposure to potentially harmful or ineffective medical goods, clinical investigations in children are crucial. 

Children are a vulnerable population that cannot give their own consent, so they are given extra protections when taking part in clinical research. 

Such precautions are a crucial need for starting and carrying out pediatric research projects as part of a programme for developing medical products. 

Source: 2019-89-DG- Ethical Consideratons for Clinical Investigations of Medical Products Involving Children (9-19-22).docx (fda.gov)

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