Pharma GMP News of the Week: 12-June-2022

Period: June 5, 2022 to June 11, 2022

PIC/S releases work plan for 2022: Key highlights – onsite and desktop assessments,  Annex 1 of the GMPs for sterile products,  GMP Guide Chapter 1  

Date of release: May 2022

Source: https://picscheme.org/docview/4697 

U.S. FDA published guideline on “Electromagnetic Compatibility (EMC) of Medical Devices”

Date of notification: June 6, 2022

The objective of this document is to provide the guidance and recommendation on analysis to assess the electromagnetic compatibility of medical devices. Also the guideline provides information to include in the labeling. This document will help to improve the consistency and helps in reviewing electromagnetic compatibility in device submissions.

Scope of the document is medical devices, that also consists of in vitro diagnostics, and accessories that are electrically powered or works using electrical or electronic circuitry. 

Source: https://www.fda.gov/media/94758/download 

U.S. FDA announced pilot for lower radiation levels for device sterilization  

Date of announcement: June 7, 2022

U.S. FDA is considering a master file pilot program for PMA (premarket approval) holders where approved devices are sterilized using radiation. 

The objective of this consideration is because of global supply chain constraints and to support sterilization supply chain resiliency. 

This program can help medical device manufacturers advance alternative ways to sterilize their approved medical devices.

Source: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices 

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices#MasterFile

EMA published its annual report of year 2021

Date of notification: June 10, 2022

The report brief about EMA’s role and preparedness for crisis and management of medicinal products and medical devices during major events and public health emergencies and facilitate faster approval of medicines. 

The report also provides information about the Agency’s activities related to its new legal mandate.

Repost also speaks about EMA’s efforts to address health needs of patients beyond the pandemic. 

As per the information on the website “EMA recommended 92 human medicines for marketing authorisation in 2021. Of these, 54 had a new active substance which had never been authorised in the EU before. This is a 38% increase compared to 2020, by far the highest number in the last five years”.

Source: https://www.ema.europa.eu/en/news/ema-publishes-annual-report-2021

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