Pharma GMP News of the Week: 6-February -2022

Period: January 30, 2022 to February 5, 2022

MHRA published guidance for “Risk-Adapted Approach to clinical trials and Risk Assessments

Through this guideline, the agency is directing to the sponsors to carryout and record a formal risk assessment as early as possible to understand that the clinical studies falls under the Clinical Trials legislation, categorization of trial and possibility of barriers in execution of the studies. The topics covered under guidance are:

• When and how to undertake the risk assessment

• Retention and distribution of the Risk Assessment

• Revision of the Risk Assessment

• Investigator site staff experience and training in clinical trials/GCP etc.

• Submission of risk assessment to the MHRA and the REC

• Benefits of the risk assessment process

• GCP Inspections

• Examples of risk assessments

Source: https://www.gov.uk/government/publications/risk-adapted-approach-to-clinical-trials-and-risk-assessments/risk-adapted-approach-to-clinical-trials-and-risk-assessments

News from EDQM on new IT tool used to for sharing of EDQM documents secure between DCEP and CEP holders or applicants during the CEP lifecycle

Date of news: January 31, 2022

Source: https://www.edqm.eu/sites/default/files/medias/pa_ph_cep_21_62.pdf

FDA has published draft guidance on “Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs”

Date of issue: February 01, 2022              

The guidance describes the process and mechanism for formal meetings between FDA and sponsors for an OTC drug.

This guidance describes the method how sponsors can receive suggestion on studies to support their applications.

The guidance also specifies types of meeting, formats of meeting, process of sponsors request, timelines of agency response on the meeting requests, package of meeting, and process of cancellation and rescheduling the meetings.

As per the guidance, there are three types of formats – Type X, Type Y and Type Z those are “otherwise stalled”, “milestone” and “meeting not fall under either of X or Y”.

Source: https://www.fda.gov/media/155864/download

PIC/S revised Guide to Good Manufacturing Practice (GMP) for Medicinal Products to include revised Annex 13 and new Annex 16.

Date of news: February 1, 2022

The revision of PIC/S Annex 13 is based on Clinical Trials on EC Regulation No. 536/2014. This guidance replaces EU Annex 13.

The Annex 16 is a new annex for the PIC/S. When the Annex 16 was adopted by EU, it was historically not adopted by PIC/S. Previously, this annex was considered by PIC/S as EU specific. After consultation of PIC/S Participating Authorities in 2017, it was considered to have beneficial to better convey expectations associated with product release

Source: https://picscheme.org/docview/4590

From next week, US FDA will resume routine domestic surveillance inspections

Date of news: February 02, 2022

On February 02, 2022, FDA announced that conducting domestic surveillance inspections will be begin from on February 07, 2022.

Source: https://www.fda.gov/news-events/press-announcements/fda-roundup-february-4-2022

FDA has published guidance on “Population Pharmacokinetics”

Date of issue: February 03, 2022              

The purpose of this guideline is to support new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drugs (IND) applicants and sponsors with respect to population for pharmacokinetic (PK) analysis.

Source: https://www.fda.gov/media/128793/download

EDQM published a guide to reminds CEP holders about their responsibilities towards their customers

Date of news: February 03, 2022

EDQM experienced recently issues that have demonstrated the lack of knowledge of some CEP holders about their responsibilities and obligation towards their customers/ marketing authorization holders. EDQM has published a guidance document describing summarized CEP holders’ responsibilities.

Source: https://www.edqm.eu/sites/default/files/medias/pa-ph-cep_21_57_1.pdf

Scroll to Top