Pharma GMP News of the Week: 26-March-2023
Period: March 19, 2023 to March 25, 2023
ICH Published Introductory Training Presentation on The ICH Q9(R1)
Date of news: March 20, 2023
In January 2023, the ICH Q9(R1) Guideline on Quality Risk Management reached Step 4 of the ICH Process.
After the acceptance of this Guideline, the Q9(R1) Expert Working Group created a Step 4 Introductory Training Presentation.
Source: ICH Q9(R1): Quality Risk Management
The European Directorate for the Quality of Medicines and HealthCare (EDQM) is requesting feedback from CEP users in preparation for the launch of CEP 2.0
Date of news: March 20, 2023
In order to implement the CEP 2.0, the European Directorate for the Quality of Medicines & Healthcare (EDQM) is looking for feedback from users of the Certification of Suitability (CEP). One of the decisions made in this regard is to replace the declaration of access box on the CEP document with a letter of access.
Users may now check to see if the draught letter template satisfies their needs by visiting the consultation space where it is now accessible for public comment. The deadline for comments on this paper is April 16, 2023. The final template will be made accessible on the EDQM website following the consultation period.
As part of the CEP 2.0 implementation, it will be necessary as of 1 June 2023 to include the EMA SPOR/OMS ORG ID and LOC ID for all organisations engaged in Certification of Suitability (CEP) dossiers in the application forms for new dossiers, sister files, changes, and renewals.
Date of news: March 20, 2023
As part of the CEP 2.0 implementation, it will be obligatory as of 1 June 2023 to include the EMA SPOR/OMS ORG ID and LOC ID for all organisations engaged in Certification of appropriateness (CEP) dossiers in the application forms for new dossiers, sister files, changes, and renewals. Updated CEP application forms will be made available in the near future.
In addition to company names and addresses, CEPs will include the ORG ID and LOC ID (unique identifiers for an organisation and its locations). Applicants must supply the data during the dossier review process for ongoing applications for which a CEP is to be granted. As a result, businesses are recommended to get an ORG ID and LOC ID as soon as feasible.
Press release from MHRA “MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years”
Date of news: March 21, 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) will implement a range of new initiatives, with the help of partners, to make it faster and easier to get authorisation and conduct clinical trials in the UK. These revisions mark the most significant revamp in UK clinical trials legislation in over 20 years, and will help to make the UK one of the greatest places in the world for patients and researchers to undertake clinical research.
MHRA Published Consultation outcome on proposals for legislative changes for clinical trials
Date of news: March 21, 2023
Working closely with the HRA, the MHRA and the Department of Health in Northern Ireland consulted on a series of recommendations to update, enhance, and reinforce UK law that supports clinical trial regulation. After reviewing over 2000 replies, we will now introduce legislation to modernise the UK clinical trials regulatory structure, which would:
a. Ensuring that patients and their safety remain at the forefront of all clinical studies, and that the benefits of clinical trials are available to everyone.
c. Provide a proportional and adaptable regulatory environment.
c. Establish the United Kingdom as a venue for international trials.
d. Offer a structure that is efficient, nimble, and adaptable to change.
Source: Consultation on proposals for legislative changes for clinical trials – GOV.UK
EMA published mid-point report on advancing regulatory science in the EU
Date of news: March 22, 2023
The European Medicines Agency (EMA) has issued a report summarising the mid-term achievements of its Regulation Science Strategy (RSS) until 2025. The report presents a summary of the key deliverables completed in the human and veterinary sectors between March 2020 and December 2022.
“The accomplishments highlighted in this report show that we have made significant progress in strengthening regulatory science to establish a more adaptable regulatory system that supports innovation in human and veterinary medicines,” said Emer Cooke, Executive Director of the European Medicines Agency.
Source: Advancing regulatory science in the EU – mid-point report published | European Medicines Agency
MHRA is Crafting text for an intended purpose in the context of Software as a Medical Device (SaMD)
Date of news: March 22, 2023
It is important to clearly define the intended purpose of a medical device in order to comply with medical device regulations. Failure to do so can make it more difficult to design a quality management system, generate sufficient clinical evidence, and implement a post-market surveillance system. The MHRA considers an inadequately defined intended purpose to be a serious failure to meet medical device requirements, which could lead to inadequate information for the safe and proper use of the device.
Properly defining the intended purpose of a medical device is essential for minimizing risks, meeting legal requirements, and demonstrating the benefits of the device. It also helps to articulate the value proposition of the device when conducting cost-effectiveness analyses for evaluation and procurement purposes. Clear definition of intended purpose is also beneficial when engaging with the wider health and social care sector.
This guidance document specifically addresses how to define the intended purpose for Software as a Medical Device (SaMD) and is intended to help SaMD manufacturers meet their legal obligations.
Source: Crafting an intended purpose in the context of software as a medical device (SaMD) – GOV.UK
