Pharma GMP News of the Week: 28-November-2021

Period: November 21, 2021 to November 27, 2021

The International Council for Harmonisation (ICH) met virtually on 17 and 18 November and Further expansion of ICH Membership and Observership

Date of news: November 25, 2021

The ICH has conducted virtual meeting on 17 – 18 November 2021 which was proceeded by ICH Management Committee and MedDRA Management Committee.

As per the ICH website, “the ICH Assembly welcomed COFEPRIS, Mexico as a new ICH Member, in addition to three new ICH Observers: EDA, Egypt, Indonesian FDA, Indonesia and SECMOH, Ukraine, bringing ICH to a total of 19 Members and 35 Observers”.

Source: https://www.ich.org/pressrelease/press-release-ich-assembly-virtual-meeting-november-2021

ICH Press Release: https://admin.ich.org/sites/default/files/inline-files/ICH43_VirtualMeeting_PressRelease_2021_1125_FINAL_0.pdf

FDA Updates on possible mitigation strategies to reduce the risk of nitrosamine drug substance-related impurities in drug products

Content current as of: November 18, 2021

FDA site suggests that “the first of these possible mitigation strategies is derived from literature reports showing that commonly used antioxidants such as ascorbic acid (vitamin C) or alpha-tocopherol (vitamin E) inhibit the formation of nitrosamines in vivo based upon data from human gastric luid in vitro studies”.

Further to this, FDA website states that “A second possible approach is based upon the fact that the formation of nitrosamines typically occurs under acidic conditions, whereas, in a neutral or basic environment, the kinetics of these reactions are significantly reduced”.

Source: https://www.fda.gov/drugs/drug-safety-and-availability/updates-possible-mitigation-strategies-reduce-risk-nitrosamine-drug-substance-related-impurities?utm_medium=email&utm_source=govdelivery

FDA published An Update to the Resiliency Roadmap for FDA Inspectional Oversight

As per the US FDA update, “since April 1, 2021, FDA conducted more than 600 domestic and more than 200 foreign remote regulatory assessments, which included review of records submitted upon request under section 704(a)(4) authority, as well as review of documents and other information voluntarily submitted upon request where section 704(a)(4) does not apply”.

As per the update, “Between April and September 2021, FDA completed 124 foreign inspections across 23 countries”.

Source: https://www.fda.gov/media/154293/download

Major update on timelines for CEP applications by EDQM

Date of news: November 26, 2021

On October 1, 2021As per the EDQM started use of a new Information Technology tool for management of CEP applications. As per the update, timelines for evaluation of all CEP applications, revisions or renewal will be specified in business days instead of calendar days.

Source: https://www.edqm.eu/en/news/change-edqm-timelines-cep-applications

EMA vision for use of real-world evidence in EU medicines regulation

Date of news: November 24, 2021

As per the vision, “the creation of the Data Analytics and Real World Interrogation Network (DARWIN EU) will be key to delivering this vision”.

As per the EMA website “article explains plans to establish methods and standards for high-quality collection and use of RWE, in cooperation with stakeholders including patients, healthcare professionals, industry, regulatory and public health agencies, health technology assessment bodies, payers, and academia”.

Source: https://www.ema.europa.eu/en/news/vision-use-real-world-evidence-eu-medicines-regulation

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