Pharma GMP News of the Week: 21-November-2021

Period: November 14, 2021 to November 20, 2021

FDA conducted a virtual public meeting on November 16, 2021, on enhanced drug distribution security at the package level

Date of last update: November 15, 2021

The purpose of this public meeting was to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to provide input to FDA on the implementation of the enhanced drug distribution security provisions of the DSCSA that go into effect in 2023.

FDA requests that stakeholders prepare comments responding to the following questions for one or more of the topics listed below:

• How is implementation of the 2023 enhanced system requirements progressing for your organization?
• What challenges is your organization facing?
• Are the proposed recommendations in FDA’s guidance on enhanced drug distribution security at the package level helpful to achieve compliance with 2023 enhanced system requirements? If not, what additional information would be useful?
• Are there areas in which FDA could provide more clarity?

Source: https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security#event-information

https://www.federalregister.gov/documents/2021/10/15/2021-22474/enhanced-drug-distribution-security-at-the-package-level-under-the-drug-supply-chain-security-act

MHRA has updated the guidance on “How investigators and sponsors should manage clinical trials during COVID-19” with respect to the section ‘Urgent Safety Measures’.

Date of update: November 16, 2021

As per MHRA guidance, “Since 16 November 2021, the notification of USMs to the MHRA should be performed following the standard procedure for USMs notifications as detailed here: Urgent Safety Measures

Source: https://www.gov.uk/guidance/managing-clinical-trials-during-coronavirus-covid-19#urgent-safety-measures

Ireland’s Health Products Regulatory Authority (HPRA) posts guide to online controlled drug license system

Date of guideline: November 16, 2021

The National Drug Control System (NDS) allows users for application of import and export licenses for the various schedules of controlled substances in Ireland.

As per the guideline “NDS Web is a highly secure online licence application system for controlled drugs. This system allows users to apply for import and export licences for Schedule 1, 2, 3 and 4, Part 1 controlled substances, and letters of no objection (LONas) for Schedule 4 part 2 controlled substances.

This guidance document outlines the information available on NOS Web and the procedure to apply for an import licence, export licence or LaNa on NDS Web”.

HPRA Guide: https://www.hpra.ie/docs/default-source/publications-forms/guidance-documents/aut-g0158-guide-to-ndsweb-extranet-v1.pdf?sfvrsn=7

Integration of EudraGMDP and OMS – Questions and answers from the webinar for industry on integration of EudraGMDP and OMS

Date of publication on EMA site: November 16, 2021

As per EMA “The new regulatory framework for veterinary medicines requires several changes to EudraGMDP. The most notable change is the integration of EudraGMDP with EMA’s Organisation Management Service (OMS).

From 28 January 2022, users of EudraGMDP from national competent authorities will no longer introduce organisational data (organisation name and location address details) directly into the relevant fields on the EudraGMDP database. Instead, they will select the relevant organisation name and location address details, including the legally registered address, of the manufacturers/importers/distributors from the Agency’s organisation dictionary (so-called OMS).”

Source: https://www.ema.europa.eu/en/events/integration-eudragmdp-oms-webinar-industry

Download Q and A: https://www.ema.europa.eu/en/documents/other/questions-answers-webinar-industry-integration-eudragmdp-oms_en.pdf

Australia’s Therapeutic Goods Administration (TGA) has published guidance on reclassification medical devices.

Published in: November 2021

As per the TGA, “From 25 November 2021, medical devices that are substances for introduction into the body will be required to meet regulatory requirements demonstrating the safety and performance for

Class IIa (low-medium risk), Class IIb (medium-high risk) or Class III (high risk) devices”.

As per the guidance, “This new classification rule is specific for devices composed of substances, or combinations of substances, that are intended to be introduced into the human body through an orifice or applied to the skin, and to be absorbed by, or locally dispersed, in the human body after introduction or application.

This aligns with EU Regulation 2017/745, rule 21 of Chapter III of Annex VIII”.

Source: https://www.tga.gov.au/sites/default/files/reclassification-medical-devices-that-are-substances-introduced-into-the-human-body-orifice-applied-the-skin.pdf

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