Pharma GMP News of the Week: 3-July-2022

Period: June 26, 2022 to Jul 2, 2022

MHRA Published Government response to consultation on the future regulation of medical devices in the United Kingdom

Document published on: June 26, 2022

MHRA had consulted on required changes to the regulatory framework for medical devices in the UK between September and November 2021.

The objective of the proposal was to get opinion on developing a future legislation for medical devices which aiming improved patient safety, transparency, 

• close alignment with international best practice, and

• more flexible, responsive and proportionate regulation of medical devices

Source: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1085333/Government_response_to_consultation_on_the_future_regulation_of_medical_devices_in_the_United_Kingdom.pdf 

Update from MHRA: Good laboratory practice (GLP) for safety tests on chemicals – Updated PDF – Current Members of the UK GLP compliance programme

Document update: June 28, 2022

Source: https://www.gov.uk/guidance/good-laboratory-practice-glp-for-safety-tests-on-chemicals#full-publication-update-history 

News from EMA – MAHs can register their Industry Single Point of Contact (i-SPOC) on supply and availability 

Date of News: June 28, 2022

As per news from EMA, now can register their i-SPOC who will inform the agency regarding the availability and supply of critical medicines in the context of a ‘public health emergency’ or a ‘major event’ .

To read more on that, refer to the link provided as source.

Source: https://www.ema.europa.eu/en/news/call-companies-register-their-industry-single-point-contact-i-spoc-supply-availability 

News from ICMRA “International pilot programmes to streamline regulatory assessments and inspections”

Month of news: June 2022

As per the news, ICMR is inviting applicants to participate in pilot programmes that have two main key area – 

a. Collaborative assessments of post-approval CMC changes 

b. Hybrid method for inspections

To read more on this, click on the following link.

Source: https://icmra.info/drupal/news/pq_pilots_call_for_industry_applications 

TGA has updated the updated its guideline “Clinical evidence guidelines for medical devices”, V3.1

Month of news: June 2022

Key updates by TGA in the guideline are as follows:

a. Updated Part 1 of the guideline “General Requirements – The Essential Principles”

b. Added New chapter “Personalised medical devices (PMDs)”

c. Updated – Total and partial joint prostheses

d. Included New chapter “Software as Medical Device”

To read more on this, click on the following link.

Source: https://www.tga.gov.au/sites/default/files/clinical-evidence-guidelines-medical-devices.pdf  

FDA proposes new rule on “Nonprescription Drug Product With an Additional Condition for Nonprescription Use:

Date of proposal: June 28, 2022

To read more on the proposal, click on the following link.

Source: https://www.federalregister.gov/documents/2022/06/28/2022-13309/nonprescription-drug-product-with-an-additional-condition-for-nonprescription-use 

FDA published draft guideline “Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments”

Document published on: June 29, 2022

The objective of this guideline is to describe how patients, caregivers, researchers, medical product developers, and other stakeholders can compile and provide feedback about patient experience data and other applicable information from caregivers and patients to be used for regulatory decision-making and product development. 

Source: https://www.fda.gov/media/159500/download

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