Pharma GMP News of the Week: 20-February -2022

Period: February 13, 2022 to February 19, 2022

EMA published list of “Principal Documents taken into account for the preparation of procedures for GCP inspections requested by the CHMP”

Date of document: February 14, 2022

The given list in the published document is not an exhaustive list. Section, “Good clinical practice”, on the EMA website also should consult for additional guidance documents.
Source: https://www.ema.europa.eu/en/documents/other/principal-documents-taken-account-preparation-procedures-gcp-inspections-requested-chmp_en.pdf

European Commission published Updated guideline “Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials”

Date of publication: February 14, 2022

Source: file:///C:/Users/krp00/AppData/Local/Temp/mp_eudralex_guideline-quality_en_0-1.pdf

European Commission published Updated guideline “Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials”

Date of publication: February 14, 2022

Source: file:///C:/Users/krp00/AppData/Local/Temp/mp_eudralex_guideline-chemical_en_1.pdf

As per EDQM news, Ph. Eur. adopts harmonised chapter on Chromatographic separation techniques (Chapter 2.2.46.)

Date of news: February 15, 2022

The text of chapter revised as per pharmacopoeial harmonisation text (agreed by Pharmacopoeial Discussion Group (PDG – the United States Pharmacopeia (USP), the Japanese Pharmacopoeia, and the Ph. Eur.). The agreement was done on September 28, 2021.

The revised text will be available in the 11th Ph. Eur. edition in the month of July 2022 and that will be implemented from 1 January 1, 2023.

Key changes are as follows:

Changes in Ph. Eur. Chapter 2.2.46.)

Source: https://www.edqm.eu/en/news/ph-eur-commission-adopts-harmonised-general-chapter-2246-chromatographic-separation-techniques

EMA published PFD on “Human medicines highlights of 2021”

Date of news: February 15, 2022

As per the EMA, it recommended 90+ medicines for MA. 53 out of them are new API first time authorized in the EU, which is 30% more than 2020. For more details, download the PDF provided in the following link.

https://www.ema.europa.eu/en/documents/report/human-medicines-highlights-2021_en.pdf

FDA released its latest quarterly batch of product specific guidances (PSGs) to support generic drug development

Date of news: February 18, 2022

As per FDA notice the guidance “provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs)”.

Source:

FDA Notice: https://public-inspection.federalregister.gov/2022-03248.pdf

https://www.accessdata.fda.gov/scripts/cder/psg/index.cfm?utm_medium=email&utm_source=govdelivery

EMA updated the Union Product Database – FAQs for industry users

Date of publication: February 18, 2022

As per the EMA, the document is a compiled FQA asked by marketing authorisation holders (MAHs) on the usage of the Union Product Database (UPD) and its answers.

Source: https://www.ema.europa.eu/en/documents/other/union-product-database-faqs-questions-answers-industry-users_en.pdf

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