Pharma GMP News of the Week: 13-April-2023
Period: April 2, 2023 to April 8, 2023
Japan’s PMDA published guidance on “System for reporting side effects and defects during clinical trials”
Month of news: April 2023
It will be necessary to use the electronic application data system to submit reports of adverse medication reactions and flaws during clinical trials starting on April 1, 2023.
Only when it is difficult to send earlier reports of adverse reactions or malfunctions from clinical trials on paper, as well as the most recent clinical trial safety reports, are they accepted via email.
Clinical trial sponsors (pharmaceutical firms, etc.) and physicians or dentists (those who conduct clinical trials themselves) are required under the Pharmaceuticals and Medical Devices Acts to report adverse responses, issues, etc. Throughout clinical trials, the Ministry of Health, Labor, and Welfare must be updated.
Statutory guidance on MHRA fees: Fees for 2023 – 2024 have increased from 2022 – 2023
Date of news: April 1, 2023
To guarantee the MHRA covers its expenditures and maintains financial stability in the coming years, new fees are being implemented for a variety of services starting on Saturday, April 1, 2023.
The increased costs will make it possible for the MHRA to provide a quick and effective regulatory service that safeguards and enhances patient and public health by easing access to superior, risk-free, efficient, and cutting-edge medical products.
The adjustments aim to achieve cost recovery in accordance with HM Treasury’s policies on managing public money in order to guarantee that reasonable and proportionate rates are established for MHRA customers. The following significant changes take effect on April 1:
– A 10% increase in all statutory fees. This represents cost increases since the most recent comprehensive MHRA prices review in 2016.
– To achieve full cost recovery, 58 rates for services that are considerably undercovering costs will be increased.
– The implementation of 18 additional service tariffs that demand cost recovery
Source: https://www.gov.uk/government/publications/mhra-fees/current-mhra-fees
Japan’s PMDA published “FAQs on Electronic Study Data Submission posted”
Date of news: April 3, 2023
The use of data-based quantitative information, including those derived from modeling and simulation (M&S) methodologies, has been aggressively encouraged in modern drug development.
In such cases, PMDA acknowledges the necessity of gathering electronic study data, processing it using cutting-edge techniques, and utilizing the results in the course of its evaluations and consultations. The utilization of such gathered data is anticipated to lessen the regulatory submission workload for sponsors, enhance PMDA’s evidence-based assessments and consultations, and result in the creation of new recommendations, all of which would eventually increase the success rate of drug development.
Source: New Drug Review with Electronic Data | Pharmaceuticals and Medical Devices Agency
FDA published guideline on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions”
Date of news: April 03, 2023
In order to protect and advance public health, FDA is providing this draft guideline to further develop a regulatory strategy suited to artificial intelligence/machine learning (AI/ML)-enabled devices.
This will enhance patients’ access to reliable AI/ML-enabled devices. As stated in the FDA’s 2019 AI/ML Discussion Paper and 2021 AI/ML Action Plan, this draft advice outlines the least onerous method to facilitate the iterative improvement of machine learning-enabled device software functions (ML-DSF) while continuing to ensure their safety and effectiveness. A Predetermined Change Control Plan (PCCP) that may be included in a marketing proposal for ML-DSF should include the information recommended in the draft advice.
The anticipated ML-DSF adjustments, the associated methods to put those alterations into practice and validate them, and an assessment of the impact of those modifications.
News from EMA “New features further strengthen Priority Medicines scheme”
Date of news: April 4, 2023
To boost its assistance for the development of medicines in areas of unmet medical needs, EMA is adding a number of new features to the Priority Medicines (PRIME) scheme. The PRIME programme makes potentially life-saving medications more readily available to patients. 26 medications that benefited from PRIME funding had been recommended for approval in the European Union by the end of 2022. (EU).
A study of the program’s first five years of use, which revealed certain chances for the programme to be strengthened further, led to the deployment of the new features.
A roadmap and product development tracker will be built for each PRIME development in order to maximize the early scientific and regulatory support given to promising treatments. While the development’s progress is continuously tracked and important topics for future discussion can be recognised during the process, both technologies will make it easier for regulators and developers to communicate continuously.
Source: New features further strengthen Priority Medicines scheme (PRIME)
FDA published draft on “Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision-Making”
Date of news: April 05, 2023
The fourth in a series of four patient-focused drug development (PFDD) methodological guidance documents, this guidance outlines how stakeholders (patients, carers, researchers, medical product developers, and others) can gather and submit patient experience data and other pertinent information from patients and carers to be used for medical product development and regulatory decision-making.
FDA published draft on “Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act”
Date of news: April 05, 2023
An industry draft guideline document titled “Notification of a Permanent Discontinuance or Suspension in Production Under Section 506C of the FD&C Act” is now available, according to the Food and Drug Administration (FDA). In order to help the Agency in its efforts to prevent or mitigate shortages, the draft guidance is intended to assist applicants and manufacturers in providing FDA timely, accurate notifications about changes in the production of specific finished drugs and biological products as well as specific active pharmaceutical ingredients (API). The proposed guidance also describes how FDA informs the public when a product is in short supply.
News from ICH – The ICH M7(R2) Guideline reaches Step 4 of the ICH Process
Date of news: April 6, 2023
On April 3, 2023, the ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the M7(R2) Addendum, “Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes,” reached Step 4 of the ICH Process.
Additionally, ICH publishes the questions and answers that go along with its “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” document, which was adopted on May 24, 2022. These documents serve to further clarify, foster convergence, and enhance harmonisation of the factors to be taken into account when assessing and controlling DNA reactive (mutagenic) impurities, which are covered in ICH M7 (R2).
Source: https://www.ich.org/news/ich-m7r2-guideline-reaches-step-4-ich-process
https://database.ich.org/sites/default/files/M7_QAs_Step_2_InformationalSlides_2020_0709_0.pdf
MHRA published guidance -Software and Artificial Intelligence (AI) as a Medical Device
Date of news: April 6, 2023
Intelligence and software play a crucial role in health and social care. Many of these items are governed as medical devices or in vitro diagnostic medical devices in the UK (IVDs). Access to significant Software Group deliverables is made available in this advice, which may be helpful.
Source: Software and Artificial Intelligence (AI) as a Medical Device – GOV.UK
EDQM published “Outcome of the 175th session of the European Pharmacopoeia Commission, March 2023”
Date of news: April 6, 2023
On March 21 and 22, 2023, the European Pharmacopoeia Commission (EPC) convened its 175th session. The European Pharmacopoeia (Ph. Eur.) Supplement 11.4 (October 2023) will publish the 84 documents that the EPC approved at this session, with an implementation date of 1 April 2024. These 84 texts contained one new general chapter and 12 new monographs.
EDQM seeks Public consultation on new general chapter on phage therapy active substances and medicinal products for human and veterinary use in Pharmeuropa 35.2
Date of news: April 6, 2023
The European Pharmacopoeia Commission (EPC) decided to create a new general chapter, Phage treatment active substances and medicinal products for human and veterinary use (5.31), and tasked the recently established Bacteriophages Working Group with the job at its 170th session (June 2021). (BACT WP).
