Pharma GMP News of the Week: 29-January-2023
Period: January 22, 2023 to January 28, 2023
News from EMA “Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications”
Date of news: January 19, 2023
The usage of the Clinical Trials Information System (CTIS) will become mandatory for new clinical trial applications on January 31, 2023, and will serve as the single point of entry for submission by sponsors and regulatory assessment. This comes after a one-year transition period in which sponsors could choose whether to submit a new clinical trial application in accordance with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which took effect on January 31, 2022.
FDA published guidance “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research Guidance for Industry”
Date of news: January 23, 2023
This guidance provides the FDA’s current thinking on a variety of clinical research topics linked to the development of human medicines including cannabis or cannabis-derived substances. A drug, according to section 201(g) of the FD&C Act, is any product designed to diagnose, cure, mitigate, prevent, or treat a disease, or any product (other than food) intended to change the structure or function of the body. In general, any product (including those containing cannabis or cannabis-derived substances) that is promoted with a therapeutic benefit claim or any other disease-related claim is considered a medication.
To be legally marketed in interstate commerce, drugs that are not biological products must either (1) receive premarket approval from the FDA through the new drug application (NDA) or abbreviated new drug application (ANDA) process, or (2) meet the requirements in the FD&C Act for marketing without an approved NDA or ANDA for certain over-the-counter nonprescription drugs. The recommendations in this advice are intended for goods that meet the FD&C Act’s legal definition of a drug.
Source: Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research
News from EU “ EU survey on the implementation of the Clinical Trial Regulation”
Date of news: January 23, 2023
News from EDQM “European Paediatric Formulary published new monograph on Simple syrup (preservative-free)”
Date of news: January 25, 2023
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has introduced a new monograph to the European Paediatric Formulary, Simple syrup (preservative-free). The monograph was authorised by the European Pharmacopoeia Commission at its 174th session in November 2022, and it was just adopted by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH). Simple syrup, which is widely used in Europe, was also utilised as the vehicle for some of the original PaedForm monographs.
Source: European Paediatric Formulary: Simple syrup (preservative-free) monograph published
News from EU “A Commission decision adopted today will contribute to improve the quality of medicines in the EU. It allows trusting on the quality of active substances produced in Canada”
Date of news: January 26, 2023
Active chemicals made in third countries such as Canada and intended for human medicines placed on the EU market must be manufactured in an EU similar regulatory regime that includes criteria for good manufacturing practises (GMP).
Third countries can ask the Commission to assess whether their regulatory framework and related control and enforcement activities provide a level of public health protection comparable to that of the Union, as Health Canada/Santé Canada, a federal department of the Canadian Ministry of Health, requested in October 2018.
Source: Improving the quality of medicines
News from ICH “Module I – Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports Training Video is now available on the ICH website”
Date of news: January 23, 2023
Module I – Introduction to E2B(R3): Electronic Transmission of Individual Case Safety Reports Training Video has been released by the ICH Secretariat.
The Training Video is available for download, and more material is accessible on the ICH E2B(R3) EWG website.
Source: https://database.ich.org/sites/default/files/E2B%20Module%20I%20Final%20-1080-%202023_0123.mp4
News from ICH “The updated ICH E2B(R3) Q&As reach Step 4 of the ICH Process”
Date of news: January 23, 2023
The ICH Secretariat is happy to inform that the updated ICH E2B(R3) Q&As Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has passed Step 4 of the ICH Process as of the 17th of January 2023.
Source: https://database.ich.org/sites/default/files/ICH_E2B-R3_QA_v2_4_Step4_2022_1202.pdf
Press release from MHRA “UK to introduce first-of-its-kind framework to make it easier to manufacture innovative medicines at the point of care”
Date of news: January 25, 2023
The Medicines and Healthcare products Regulatory Agency (MHRA) stated today that the United Kingdom will be the first country to implement a bespoke framework for the regulation of innovative products made at the point of care. This means that new medications with very short shelf life and highly personalized treatments can be manufactured in or near a hospital setting or ambulance and delivered to patients much more swiftly.
News from ICH “The ICH M13A draft Guideline presentation available now on the ICH website”
Date of news: January 26, 2023
The M13 Expert Working has produced a Step 2 Informational Presentation in response to the ICH M13A draught draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reaching Step 2b of the ICH Process in December 2022.
More information is available on the M13 page, including a copy of the Step 2 Informational Presentation.
Source: https://database.ich.org/sites/default/files/ICH_M13A_Step2_draft_Guideline_2022_1125.pdf
News from ICH “The ICH Q13 Introductory Training Presentation is now available on the ICH website”
Date of news: January 26, 2023
On November 16, 2022, the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 4 of the ICH Process.
Following the acceptance of this Guideline, the Q13 Expert Working Group created a Step 4 Introductory Training Presentation.
The presentation is available for download on the Quality Guidelines website.
Source: https://database.ich.org/sites/default/files/ICH%20Q13_Step_4_Presentation_2023_0112_0.pdf
