Pharma GMP News of the Week: 15-May-2022

Period: May 8, 2022 to May 14, 2022

EMA updated “Annex IV to procedure for conducting GCP inspections requested by the CHMP: Sponsor and Contract Research Organisations (CRO)”

EMA/INS/GCP/155794/2022

Date of update: May 05, 2022

Source: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/annex-iv-procedure-conducting-gcp-inspections-requested-chmp-sponsor-contract-research-organisations_en.pdf 

Medical Device Coordination Group Document guidance provides clarity on permitted changes to devices launched ahead of IVDR

Month of publication: May 2022

Source: https://ec.europa.eu/health/latest-updates/mdcg-2022-6-guidance-significant-changes-regarding-transitional-provision-under-article-1103-ivdr-2022-05-04_en 
https://ec.europa.eu/health/system/files/2022-05/mdcg_2022-6.pdf

US FDA published draft guideline on “Benefit-Risk Considerations for Product Quality Assessments”

Date of issue: May 09, 2022

The objective of this draft guideline is to provide information about benefit-risk principles applied by FDA when conducting product quality-related assessments of CMC information that have been submitted as part of original NDAs, BLAs  in addition to other information available to FDA during its assessment.

The guidance covers details of sources of uncertainty and probable mitigation strategies with respect to product quality issues that may have potential effect on a product.

While considering the application, the agency considers the overall benefit and risk, and residual risk regarding unresolved product quality issues. The document discusses how to deal with unresolved product quality issues which can be addressed as part of regulatory decision making.

Source: https://www.fda.gov/media/158204/download 

MHRA blog publishes “Compliance Monitor Process (Part 2) – CM role and application process” 

Date of issue: May 10, 2022

On May 10, 2022 second part a two-part blog series on the CM Process that was piloted by the MHRA from April 2022. The second part of the blog gives information on the application process and CM role.
Source: https://mhrainspectorate.blog.gov.uk/2022/05/10/compliance-monitor-process-part-2-cm-role-and-application-process/

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