Pharma GMP News of the Week: 13-November-2022

Period: November 6, 2022 to November 12, 2022

Europe’s contribution of worldwide drugs R&D has shrunk by a fourth in the last two decades, as the sector’s decreasing patterns continue.

Date of news: November 7, 2022

Europeans are losing access to new medications and the chance to participate in groundbreaking clinical trials as research and development of new therapies shifts to more ambitious life science industries in the United States and Asia.

A new research for EFPIA published today by Charles River Associates offers a troubling picture of Europe’s declining competitiveness, with the worldwide share of pharmaceutical R&D expenditure, clinical trials, and manufacturing output all shrinking. The problem is particularly serious for Advanced Treatments Medicinal Products (ATMPs), which are tissue, gene, and cell therapies intended to prevent, treat, and cure uncommon illnesses such as certain cancers, and where the US and China dominate.

Source: Europe’s share of global medicines R&D shrinks by a quarter in 20 years – as sector’s declining trends continue 

The Indian Pharmacopoeia Commission provides clarification on the application of new general chapters.

Date of news: November 7, 2022

In response to stakeholder issues concerning implementation and compliance, the Indian Pharmacopoeia Commission (IPC) defined the obligations imposed by three new general chapters.

The Indian Pharmacopoeia’s ninth edition, published in July, included chapters on dosage unit homogeneity, elemental contaminants, and nitrosamine impurities. The announcement issued last week describes how the three new general chapters would affect pharma producers.

The consistency of dosage units chapter was developed by IPC for “information and awareness,” but it is not cited in individual monographs, thus adoption remains voluntary. Adoption of the elemental impurities chapter is also optional, while IPC adds that it will gradually replace the heavy metals test in individual monographs to make it mandatory in the 2026 edition.

The monographs for sartan active medicinal components refer to the third chapter on nitrosamine impurities. IPC expects other medication producers to follow the general guidelines and test for nitrosamine contaminants wherever “suitable and required.”

Source: IPC’s Notice Regarding General Chapters of IP 2022 – Indian Pharmacopoeia Commission 

FDA published draft guideline on “Sameness Evaluations in an ANDA – Active Ingredients”

Date of news: November 8, 2022

The guidance is intended to assist applicants preparing an abbreviated new drug application (ANDA) by providing recommendations on demonstrating similarity between the active ingredient in a proposed generic drug product and its reference listed drug (RLD), as required by section 505(j)(2)(A)(ii) of the FD&C Act and FDA regulations of § 314.94(a)(5) (21 CFR 314.94(a)(5)).

Source: Sameness Evaluations in an ANDA — Active Ingredients 

MHRA updated guideline “Clinical trials for medicines: manage your authorisation, report safety issues”

Date of news: November 8, 2022

Source: https://www.gov.uk/guidance/clinical-trials-for-medicines-manage-your-authorisation-report-safety-issues#full-publication-update-history 

MHRA Return to International GMP Inspections

Date of news: November 8, 2022

The MHRA Inspectorate made a blog post in March 2020 in which MHRA declared that they will only perform on-site inspections related to the UK Government’s COVID-19 response or any other potential major public health risk until further notice. MHRA provided an update in July 2020 outlining our plans to resume a full programme of UK on-site inspections in October 2020. MHRA was unable to plan for a return to international inspections at the moment, but we promised to give more information as the situation progressed.

Source: Return to International GMP Inspections – MHRA Inspectorate 

FDA published draft guideline on “Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin”

Date of news: November 11, 2022

The guideline explains what data should be given in marketing application and registration packages for biotechnology goods, as well as what data should be tested and evaluated for viral safety. Biotechnology products include biotherapeutics and various biological products developed from cell cultures established from human or animal cell banks (e.g., mammalian, avian, insect). The term “virus” in this article excludes non-conventional transmissible agents such as those associated with mammalian prions (e.g., bovine spongiform encephalopathy, scrapie). Applicants are recommended to consult with the appropriate regulatory authorities about issues related to bovine spongiform encephalopathy.

Source: Q5A(R2) Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin 

FDA published final guideline on “Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents”

Date of news: November 14, 2022

This guideline is being issued by FDA to clarify our approach to referring to the terms “device” and “counterfeit device” in FDA publications. For many years, the concept of “device” has been established in FD&C Act section 201(h). The definition of device was renamed to section 201(h)(1) of the FD&C Act upon the passage of the Safeguarding Therapeutics Act in January 2021, and the new term “counterfeit device” and its meaning were designated at section 201(h)(2) of the FD&C Act. The FDA is publishing this guideline to clarify how we plan to refer to the terms “device” and “counterfeit device” in guidance, regulatory papers, communications, and other public publications, as well as how we expect to interpret current references to section 201(h) of the FD&C Act.

Source: Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Commun

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