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

Period: February 6, 2022 to February 12, 2022

EMA updated “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”

Date of news: February 04, 2022

The EMA has updated question and answer guidance to provide guidance on how (MA) marketing authorization holders supposed to identify the risk and control it  with respect to nitrosamines identified in formulation and active ingredients (APIs).

The guidance includes “Decision tree with control options for products containing multiple N-nitrosamines”

As per the guidance, there are following two acceptable options for determining nitrosamine limits when there are more than nitrosamines available. The approach helps to ensure not to exceed the acceptable risk level of 1:100,000 as outlined in ICH M7(R1) guideline:

  • The sum of daily expose/ intake of all identified N-nitrosamines should not to be exceed the Acceptable Intake of the identified most potent N-nitrosamine
  • The sum of all calculated N-nitrosamines risk level should not be exceeded is 1 in 100,000

Source: https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a53-1490-questions-answers-marketing-authorisation-holders/applicants-chmp-opinion-article-53-regulation-ec-no-726/2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf

FDA published draft guidance “Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry”

Date of news: February 07, 2022

The purpose of the graft guidance is:

  • To provide recommendations and assist industries and parties involved in the development of antibody-drug conjugates (ADCs) with a cytotoxic small molecule drug or payload.
  • The guidance reflects the FDAs current thinking on
    • Clinical pharmacology considerations
    • Recommendations for development that includes bioanalytical methods, dosing strategies, dose- and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and drug-drug interactions (DDIs).
  • Specific emphasize on clinical pharmacology considerations of ADC development programs with appropriate reference.

Source: https://www.fda.gov/media/155997/download

Date of news: February 08, 2022

Purpose of this policy document is FDA’s concerns regarding safety of human. The guidance discourages development, approval, and usage authorization for sanitation tunnels (also called as disinfection/ sanitizing tunnels)

Examples are chambers, walkways, or similar arrangements that is made using sensor operated spray with a mist of sanitizing solution that gets sprayed when they passes through these tunnels.

Source: https://www.fda.gov/media/156027/download

EDQM have announced a Ph. Eur. tentative policy on assay RSDs

Date of news: February 09, 2022

As per EDQM, this tentative policy is applicable for monographs on medicinal products with chemically defined active substances – End of trial period postponed.

Source: https://www.edqm.eu/en/news/ph-eur-tentative-policy-assay-rsds-monographs-medicinal-products-containing-chemically-defined

MHRA has published article on MHRA blog on “New year, new standards for investigational medicines”

Date of news: February 10, 2022

Recently, Clinical Trial regulation came into effect in the EU, “the Commission guidelines on good manufacturing practice for investigational medicinal products for human use” (It is revised Annex 13 of EU GMP).

Even though the EU is EU CTR will not be applicable for UK, the UK requirements will not get changed until completion of consultation on legislation for new proposals with respect to UK clinical trial. As per the blog, UK will be aligned with the globally harmonised standards of PIC/S and the EU, including requirements for the Qualified Person.

Source: https://mhrainspectorate.blog.gov.uk/2022/02/10/new-year-new-standards-for-investigational-medicines/

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