Last week’s round-up; 11 – 15 May 2020
EMA: WORK PLAN 2020 OF THE GOOD CLINICAL PRACTICE INSPECTORS’ WORKING GROUP (GCP IWG)
The GCP IWP has published its meeting dates and a list of its priorities for 2020. The priorities of the group will continue with an EU focus and maintaining international relationships. However, of particular interest is the upcoming work to create and finalise a series of Q&As on the following noteworthy topics Q&A on inspectors’ access to patients’ medical records/data when the access of EEA inspectors to medical information is not clearly stated in the Informed Consent Form (ICF). Q&A on sponsor oversight of activities subcontracted to third parties. Q&A on expectations for provision of written information to clinical trial subjects in relation to new information requiring re-consent. Q&A on confidentiality undertaking of EU/EEA inspectors.
The full entirety of the work plan can be found under this link: https://lnkd.in/djgDh2T
DASATINIB PRODUCT-SPECIFIC BIOEQUIVALENCE GUIDANCE
The EMA’s Dasatinib product-specific bioequivalence guidance is currently under revision. A revised draft guideline has been released for public consultation and comments will be received until 31st August 2020. The current adopted guidance concerns bioequivalence testing requirements for Dasatinib 20, 50, 70, 80, 100 and 140 mg film-coated tablets. The draft revised document also includes requirements for Dasatinib 10 mg/ml suspension and the additional requirement for a fed study for both dosage forms.
CMDh has updated the following guidance: – RMS validation checklist for human medicinal products in DCP – Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/Recommendation papers – Data requested for Variations and/or Renewal Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume 2B, Presentation and format of the dossier Common Technical Document (CTD) and/or in the EEA approved Guidelines/ Recommendation papers – CMDh Best Practice Guide on the use of the electronic Common Technical Document (eCTD) in the Mutual Recognition and Decentralised Procedures – CMDh Questions & Answers on implementation of outcome of Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group – Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP.
The updated documents (most with tracked changes) may be viewed here: https://bit.ly/RealCMC-2T4PycX
MHRA GUIDANCE: MEDICAL DEVICES CLINICAL INVESTIGATIONS DURING COVID-19
The MHRA has recently adopted a flexible and pragmatic approach to regulatory requirements for medical device clinical investigations during the COVID-19 pandemic. This is documented in Guidance “Medical devices clinical investigations (CIs) during the coronavirus (COVID-19) outbreak”. The updated guidance, which now includes a new section relating to COVID 19, details regulatory flexibilities introduced for ongoing and new submissions for CIs.
There is an expedited process in place for CIs directly relating to COVID-19. However, it states that if MHRA is unable to reach a decision by the new internal deadline, the 60-day assessment period still applies, and the applicant cannot start the study until they have received a final decision from the MHRA or until 60-days after the notification. The update also states that the MHRA is working on a process for studies where there is both a medicine and a medical device to allow for a single application via the Clinical Trials Unit to ensure a smooth and fast assessment of both elements.
The guidance document which can be accessed via this link: https://bit.ly/2zymV0Y
SUSPENSION OF RANITIDINE MEDICINES IN THE EU
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended the precautionary suspension of all ranitidine medicines in the EU due to the presence of low levels of the potentially carcinogenic impurity, N-nitrosodimethylamine (NDMA).
Many European national authorities had already recalled ranitidine medicines as a precautionary measure during the EMA’s review. There is some evidence which shows that NDMA may form from the degradation of ranitidine itself over the course of its shelf-life, however, it is still unclear whether the impurity can also be formed from ranitidine inside the human body.
The CHMP recommendation will be forwarded to the European Commission, which will issue a final legally binding decision applicable in all EU Member States.
OUTCOME OF THE 166TH SESSION EUROPEAN PHARMACOPOEIA COMMISSION
The 166th European Pharmacopoeia (Ph.Eur.) Commission session was still held electronically despite the restrictions and lockdowns brought on by the COVID-19 pandemic. During the Ph.Eur. Commission session, 91 texts, including 11 new texts, were adopted and will be published in the Ph. Eur. Supplement 10.4 and effective from 1st April 2021.
The new texts include general chapter 5.28 on Multivariate Statistical Process Control and monographs for Regorafenib Tablets, Riociguat Tablets, Rivaroxaban Tablets and Sorafenib Tablets. A list of the adopted texts will soon be available on the EDQM website. Monographs for sartan drug substances have also been revised to add a requirement for risk assessment of the manufacturing process and to replace interim limits for NDMA and NDEA with a 0.03 ppm limit. The next Ph. Eur. Commission session is due to take place on 23rd June 2020.