Pharma GMP News of the Week: 10-April-2022

Period: April 03, 2022 to April 09, 2022

MHRA update: “Medicines: reclassify your product – Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification”

Date of Update: April 4, 2022

Update: Updated Approved reclassifications to Mar 31, 2022

Source: https://www.gov.uk/guidance/medicines-reclassify-your-product

The FDA Office of Pharmaceutical Quality published a white paper “Quality Management Maturity: Essential for Stable U.S. Supply Chains of Quality Pharmaceuticals”

Date of white paper: April 05, 2022

The white paper is published with the aim of having a maximally efficient, agile, flexible manufacturing sector that reliably produces high-quality drug products without extensive regulatory oversight.

Manufacturers reach to the quality management maturity (QMM) state when they have reliable, consistent, and robust processes to run business that achieves quality objectives and also it promotes continual improvement.

Source:

https://www.fda.gov/media/157432/download?utm_medium=email&utm_source=govdelivery

https://www.fda.gov/drugs/pharmaceutical-quality-resources/cder-quality-management-maturity

News from ICH “The ICH E11A draft Guideline reaches Step 2 of the ICH process”

Date of news: April 5, 2022

ICH E11A draft Guideline is open for public consultation as per the ICH news.

This guideline provide information related to

  • The Paediatric extrapolation
  • approaches that can be used and systematic approach for paediatric extrapolation
  • Study designs and statistical analysis methods that can be usedfor a paediatric drug development plan.

Source: https://database.ich.org/sites/default/files/ICH_E11A_Document_Step2_Guideline_2022_0404_0.pdf

FDA published draft guidance “M7(R2) Addendum: Application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes”

Date of issue: April 06, 2022

Source: https://www.fda.gov/media/157451/download

News from EDQM: EDQM Call for experts to join the Ph. Eur. network!

Date of news: April 06, 2022

The European Pharmacopoeia (Ph. Eur.) is looking for scientific experts independent to collaborate with EDQM experts and working parties.

Who can apply: It includes professionals from official medicines control laboratories, pharmacopoeial authorities, inspectorates, licensing authorities, private sector such as chemical or pharmaceutical industries, research organisations, academia, and other experts.

Source: https://www.edqm.eu/en/-/call-for-experts-join-the-ph.-eur.-network-2

FDA published final guidance “E8(R1) General Considerations for Clinical Studies”

Date of issue: April 08, 2022

The objective of this guideline is to help to design clinical studies, and to improve the quality of the studies to be submitted to regulatory agencies.

This includes:

(1) Protecting participants and getting reliable and significant results

(2) Address broad design

(3) Provide reference of other ICH guidance to conduct clinical research

Source: https://www.fda.gov/media/157560/download

FDA published draft guidance “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

Date of issue: April 08, 2022

The scope of this guidance is applicable to medical devices having software/ firmware/ programmable logic and software as a medical device.

The scope is not limited to medical devices with network or other mode of connecting capabilities.

The guidance provides information regarding the cybersecurity that should be submitted while premarket submission of following types:

De Novo requests, Premarket Notification (510(k)) submissions, Premarket Approval Applications (PMAs) and PMA supplements, Investigational Device Exemption (IDE) submissions, Product Development Protocols (PDPs) and Humanitarian Device Exemption (HDE) submissions.

Source: https://www.fda.gov/media/119933/download

News from MDCG (Medical Device Coordination Group) – “Joint implementation and preparedness plan for Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)”

Month of News: April 2022

Source: https://ec.europa.eu/health/system/files/2022-04/md_joint-impl-plan_en.pdf

News from CDSCO, India: BSE certificates is not required if materials come from negligible risk countries

Month of News: April 2022

It has been proposed by India for its Medical Device Rules, 2017 that certain transmissible disease certificates are not required when sourcing animal products from negligible-risk countries.
 
Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=ODI4Nw==

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