Pharma GMP News of the Week: 27-February -2022

Period: February 20, 2022 to February 26, 2022

As per EMA website “European medicines regulatory network adopts EU common standard for electronic product information”

Date of news: February 22, 2022

On adoption of this process, it will provide key benefits of providing up-to-date and unbiased information to the patients regarding all the medicines approved in EU through the electronic means.

This will also include the product information of a medicine and will be helpful for healthcare professionals for all the medicines approved and authorized within the region of European Union.

Source:

https://www.ema.europa.eu/en/news/european-medicines-regulatory-network-adopts-eu-common-standard-electronic-product-information

https://www.ema.europa.eu/en/documents/report/report-public-consultation-eu-common-standard-electronic-product-information-epi-summary-comments_en.pdf

EDQM towards making remote inspection as a permanent element of EDQM’s inspection scheme!

Date of news: February 23, 2022

In view of pandemic in 2020, there was an interruption in the inspection programme of the European Directorate for the Quality of Medicines & HealthCare (EDQM). This situation lead EDQM to think on alternative approach of inspection and EDQM came up with Real-Time Remote Inspections (RTEMIS) to evaluate the company’s GMP compliance using live video streaming of facility and interaction with the manufacturing sites. They have started pilot phase in the month of November 2020 and carried out several remote inspection.

Based on plot phase, EDQM has arrived at conclusion that the approach is suitable to become an integral part of its inspection system. Now, in 2022, CEP applications may get notification for Real-Time-Remote Inspections as part of approval process.

Source: https://www.edqm.eu/en/news/edqm-remote-inspections-pilot-phase-permanent-element-edqms-inspection-scheme

https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compilation-union-procedures-inspections-exchange-information_en.pdf

MHRA announced “MHRA Good Practice Symposia Week (7 to 11 March 2022)” on its Blog site

Date of news: February 24, 2022

As per the website, MHRA will be hosting series of Symposia on Good Practice. It will be live stream and online event. This can be accessed by registered delegates as recordings after the symposium. The purpose of recording is to prevent difficult situation because of different time zone of attendees and people may not be able to watch completely in real time.  

You can find more about this at https://mhra-good-practice-symposia.co.uk/home.

Source: https://mhrainspectorate.blog.gov.uk/2022/02/24/mhra-good-practice-symposia-week-7-to-11-march-2022/

FDA released new guidance on “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients”

Date of news: February 25, 2022

The objective of this guidance is to describe how stakeholders such as researchers, patients, medical product developers, and others should collect and submit the data that is related to the patient experience and other associated information from patients and caregivers. This is the second guideline in a series of four guidelines to provide methodological Patient Focused Drug Development.

Source: https://www.fda.gov/media/131230/download

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