Pharma GMP News of the Week: 30-October-2022
Period: October 23, 2022 to October 29, 2022
European Commission (EC) Decision Reliance Procedure updated email address from IPUenquiries@mhra.gov.uk to RIS.NA@mhra.gov.uk for enquiries on submitting applications for orphan designations.
Date of news: October 24, 2022
Source: European Commission (EC) Decision Reliance Procedure – GOV.UK
The UK postpones the new Medical Device Regulations by a year.
Date of news: October 25, 2022
The UK government has decided to take a stance that “supports system preparedness and reduces the risk of supply interruptions” by delaying the introduction of the future medical device regulations. The revised regulation’s intended implementation date is now July 2024.
In order to minimise the potential of disruption, the government justified the postponement by saying that it would “ensure that there is a reasonable approach to its implementation.” The usage of an EU-compliant approval procedure was recently extended by 12 months by the Medicines and Healthcare Products Regulatory Agency (MHRA).
ICH published Introductory Training Presentation on E19 on its website
Date of news: October 25, 2022
This Guideline is designed to give globally harmonised recommendations on the use of selective safety data collecting – by modifying the manner of safety data collection, it may be able to carry out clinical trials with improved efficiency by simplifying the data gathering process.
This might make large-scale effectiveness and safety clinical studies with huge numbers of participants and long-term follow-up easier to undertake.
Source: https://database.ich.org/sites/default/files/ICH_E19_Step_4_Presentation_2022_1012.pdf
FDA published final guidance on “Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions”
Date of news: October 26, 2022
The purpose of this guidance document is to assist Food and Drug Administration (FDA) staff in formulating a request for further information in compliance with the Least Burdensome Provisions of the FD&C Act in order to reach a judgement regarding a medical device marketing application. A “deficiency” is the term for such an FDA request for additional information. In order to make the best use of both industry and FDA’s time, this advice also offers suggested formats for FDA personnel to utilise when communicating shortcomings and for industry to use when responding to such requests.
For the purpose of facilitating a productive review process, this guidance contains illustrations of well-constructed flaws and industry answers. Additionally included in this guidance are supervisory review, major/minor problems, additional factors, and the order in which deficiencies should be addressed in FDA deficiency letters.
FDA published draft guidance on “Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention”
Date of news: October 27, 2022
The Food and Drug Administration has made a proposed guidance for industry titled “Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention” availabl. The goal of this proposed guideline is to aid sponsors in the clinical development of medications for the treatment, reduction of recurrence, or prevention of Clostridioides difficile infection (CDI).
MHRA has updated guideline on Guidance on pharmacovigilance procedures
Date of news: October 28, 2022
The Pharmacovigilance Procedures guideline has been amended to incorporate more information on MHRA submission requirements, particularly for signals, Risk Management Plans (RMPs), and Post Authorisation Safety Studies (PASS). The section on Periodic Safety Update Reports (PSURs) has been amended with additional requirements for PSUR filing for Northern Ireland-approved items. Additional sections on MHRA Safety Reviews and Safety Communications have been added.
