Pharma GMP News of the Week: 8-May-2022

Period: May 1, 2022 to May 7, 2022

EC proposed European Health Data Space to enable research opportunities

Date of news: May 3, 2022

The European Commission launched the EHDS (European Health Data Space). It will help the European Union to support the way healthcare is provided to people across Europe. This launch will enable people to control and use their data in other Member States or in their home country. 
Source: https://ec.europa.eu/commission/presscorner/detail/en/ip_22_2711

New on by ICH: “The Model-Informed Drug Development (MIDD) Discussion Group, which was established in January 2021, has provided as an output of its discussions, considerations with respect to future MIDD related guidelines in the form of a “roadmap”.”

Date of news: May 3, 2022

Source: 

https://ich.org/news/midd-dg-guidance-roadmap

https://www.ich.org/page/reflection-papers

MHRA updated its guidance “Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland”

Date of update: May 04, 2022

The guidance is updated for “Register of Written Confirmations for UK active substance manufacturers”.

Source: https://www.gov.uk/government/publications/exporting-active-substances-manufactured-in-great-britain-for-use-in-eea-and-northern-ireland#full-publication-update-history  

International Medical Device Regulators Forum (IMDRF) proposed document, “Principles and Practices for the Cybersecurity of Legacy Medical Devices” for public comment

Date of news: May 04, 2022

Source: https://www.imdrf.org/consultations/principles-and-practices-cybersecurity-legacy-medical-devices 

EDQM published new on “New policy for the development of monographs on medicinal products containing chemically defined active substance hydrates or solvates”

Date of news: May 5, 2022

As per the news Ph. Eur. commission approved a new policy for the development of monographs on medicinal products containing chemically defined active substances in hydrate or solvate form on its 172nd session in March 2022.

In this policy the difference between hydrates and solvates is explained. Hydrates are which have H2O as the solvent molecule.

The solvates are those that have an organic solvent.

Source: https://www.edqm.eu/en/-/new-policy-for-the-development-of-monographs-on-medicinal-products-containing-chemically-defined-active-substance-hydrates-or-solvates 

US FDA published draft guideline on “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program”

Date of issue: May 06, 2022

FDA has announced a 3rd party quality maturity appraisal and continuous improvement program.

The intent of this program is to improve medical device quality and production. This is a voluntary program and does not mandate anyone to abide by the requirement. In this program participating manufacturer’s capability and performance will get reviewed with respect to key business processes. For more details, refer to the guidance. 

Source: https://www.fda.gov/media/158180/download 

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