Pharma GMP News of the Week: 5-February-2023
Period: January 29, 2023 to February 4, 2023
In-person formal meetings with the FDA will resume in February.
Date of news: January 30, 2023
News from EDQM – CEP holders – How to submit a nitrosamine risk assessment
Date of news: January 30, 2023
The European Directorate for the Quality of Medicines & Healthcare (EDQM) would like to call CEP holders’ attention to the following information regarding minor amendments in order to assist the prompt acceptance of suggested changes.
Minor revisions should be submitted for updated discussions on impurities in section 3.2.S.3.2 or for submission of nitrosamine risk assessments (the deadline for the latter was 31 July 2020; for more information, see the news article from 27 March 2020 titled “Deadline extension to all CEP holders to complete step 1 Risk Assessments regarding presence of nitrosamines (now 31 July 2020)”). Additionally, CEP holders are reminded that changes to the synthesis or the control strategy should be classified appropriately in accordance with the EDQM guideline in order to prevent or completely eliminate the possibility of the production of nitrosamine impurities or other mutagenic impurities (minor, major revision or sister file application).
EC published Video recordings and presentations of Multistakeholder Event of Biosimilar medicines (13 December 2022)
Date of news: January 30, 2023
Source: Biosimilar medicines – Multistakeholder Event
EC Published “Clinical Trials Regulation (EU) No 536/2014 in practice”
Date of news: January 30, 2023
This is a brief overview of the key provisions of the Clinical Trials Regulation (EU) No 536/2014 (CTR) for sponsors with ongoing or planned national or international clinical trials in the European Union (EU) or European Economic Area (EEA). The Eudralex Volume 10 website publishes the list of papers that apply to clinical trials authorised under Regulation (EU) No 536/2014. The Questions and Answers document – Regulation 536/2014 (Q&A -CTR) in chapter V is the first document that is suggested for reading. Chapter 6 provides additional documents (guidelines, guidances, suggestion papers, and Q&As) to be taken into consideration.
US FDA published draft guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”
Date of news: January 31, 2023
This guideline is meant to offer suggestions on how to conduct bioequivalence (BE) studies for orally administered immediate-release (IR) 5 solid oral dosage forms intended to deliver medications to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension, during both the development and post approval phases.
Source: M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms
MHRA has published “Consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees“
Date of news: January 31, 2023
In accordance with Section 45(1) of the Medicines and Medical Devices Act 2021, the MHRA coordinated a joint consultation with the Department of Health in Northern Ireland on proposed changes to the MHRA’s statutory fees.
The consultation sought opinions on proposed changes to the statutory fees levied for the MHRA’s regulatory services between August 31, 2022, and November 23, 2022. According to the Rules for Managing Public Money, the fees are determined on a cost recovery basis; nevertheless, they have not been revised in a while and do not fully recover expenses.
News from EDQM “SNOMED International and the EDQM collaborate on map development”
Date of news: January 31, 2023
An agreement controlling the development, upkeep, and dissemination of a map connecting the terminologies of both organisations has been signed by SNOMED International and the European Directorate for the Quality of Medicines & Healthcare (EDQM), Council of Europe. September 2022 saw the implementation of the accord.
News from EMA “Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU”
Date of news: January 31, 2023
All initial clinical trial applications in the European Union (EU) must be submitted through the Clinical Trials Information System starting on January 31, 2023. (CTIS). For the submission and evaluation of clinical trial data, CTIS is now the single point of entry for sponsors and regulators of clinical studies. This comes after an interim period of one year during which sponsors could decide whether to submit an application for a new clinical trial in the EU/EEA in accordance with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which took effect on January 31, 2022.
MHRA has published guidance “Completed Paediatric Studies – submission, processing and assessment”
Date of news: February 1, 2023
MHRA published Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
Source: Completed Paediatric Studies – submission, processing and assessment – GOV.UK
New GDP Guidance Documents are adopted and put into effect by PIC/S.
Date of news: February 1, 2023
An “Aide-Memoire on the Inspection of Good Distribution Practice for Medicinal Products in the Supply Chain” (PI 044-1) and a “Questions & Answers (Q&A) document regarding the PIC/S GDP Guide” (PS/INF 22/2017) are two documents that PIC/S has released as guidelines for GDP inspectors. The PIC/S Expert Circle on GDP, headed by Karen Ford (South Africa / SAHPRA), created these documents, which will take effect on February 1st, 2023.
Source:
- AIDE – MEMOIRE INSPECTION OF GOOD DISTRIBUTION PRACTICE (GDP) FOR MEDICINAL PRODUCTS IN THE SUPPLY CHAIN
- Questions & Answers for PIC/S GDP Guide Q&A Document
News from EDQM “Ph. Eur. launches public consultation on two chapters on pharmaceutical technology procedures”
Date of news: February 1, 2023
Two texts dealing with pharmaceutical technology, one revised and one new, have recently been published in Pharmeuropa 35.1 for public consultation.
- Revision of the harmonised general chapter 2.9.3. Dissolution of tablets and capsules
- New general chapter 2.9.55. Characterisation of powder behaviour during compression
US FDA published draft guideline “Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products”
Date of news: February 2, 2023
This guidance offers suggestions to sponsors and researchers thinking about using externally controlled clinical trials to demonstrate the efficacy and safety of a new product. In an externally controlled study, results are compared between participants who got the test therapy in accordance with a protocol and a group of individuals outside the experiment who had not received the same treatment. The external control arm may consist of a group of people who have received treatment or have not (historical control) or it may consist of a group who have received treatment or have not (concurrent control) during the same time period but in a different location.
News from EMA “A new role for EMA in monitoring and mitigating critical medical device shortages during public health emergencies”
Date of news: February 2, 2023
As of today, February 2, 2023, EMA will also be in charge of monitoring and reducing shortages of essential medical equipment during situations involving a public health emergency. The new requirements are the final piece of Regulation (EU) 2022/123 to be implemented, which strengthens the EMA’s involvement in crisis management of vital pharmaceuticals and medical devices during public health emergencies.
News from EMA “Public consultation on a multi-stakeholder platform to improve clinical trials in the EU”
Date of news: February 3, 2023
A public consultation on the creation of a multi-stakeholder platform to enhance clinical trials in the European Union is set to begin on February 3, 2023, by the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA), and the European Commission (EC) (EU). A deliverable of the collaborative project Accelerating Clinical Trials in the EU is the multi-stakeholder platform (ACT EU).
Collaboration amongst a variety of stakeholders is necessary for successful clinical studies. In order to improve the clinical trials landscape for innovation and the benefit of all European people, the establishment of a unified platform will facilitate interactions between stakeholders at the EU level. This will foster a shared understanding and enable concerted action.
Source: https://www.ema.europa.eu/en/news/public-consultation-multi-stakeholder-platform-improve-clinical-trials-eu
