Last week’s round-up, 09 – 13 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud


Advice For Management Of Clinical Trials In Relation To Coronavirus

13 March 2020

In view of the current Covid-19 pandemic, the MHRA Inspectorate has released advice with regards to the management of clinical trials.

Due to restrictions to limit the spread of the coronavirus, patients with medical conditions may be advised to avoid hospitals, doctors’ clinics and crowded areas to reduce the risk of infection. Others may be under quarantine or in isolation as a form of prevention. An increasing proportion of staff at clinical research organisations have also started teleworking.

This has led to deviations from protocols and standard operating procedures due to missed visits and changes in the clinical trial process. Difficulties in obtaining wet-ink signatures on time may also lead to delays.

The MHRA has advised CROs and sponsors to ensure that such deviations are well documented to ensure that trials may be evaluated appropriately. Unless there is a risk to the patients, increases in protocol deviations related to coronavirus, do not constitute a serious breach and need not be reported. However, if a trial is halted due to logistical reasons, a substantial amendment should be submitted. Further advice is available here:

Swiss And Korean Regulators Agree To Mutually Recognize GMP Inspections

12 March 2020

The Swiss and South Korean competent authorities have agreed to mutually recognize good manufacturing practice (GMP) inspection results for pharmaceutical products.

This agreement should help facilitate the trade of pharmaceuticals between the two countries by increasing the efficiency of the regulatory processes involved in the authorisation and monitoring of medicinal products. This mutual agreement will also allow for the sharing of documents, inspection reports and other information.

As of February 2019, the Swiss regulator had started entering GMP compliance and manufacturing authorizations into the EU’s EudraGMDP database, as part of a mutual recognition agreement between the EU and Switzerland.

Testing Lab Challenges FDA Findings That Carcinogens In Metformin Do Not Exceed Acceptable Levels

11 March 2020

The FDA’s findings that nitrosamines in metformin do not exceed acceptable levels have been challenged.

Last month, the FDA stated that its testing of diabetes medicine metformin did not find unacceptably high levels of N-nitrosodimethylamine (NDMA). But testing lab and online pharmacy, Valisure, has challenged these findings in a new public citizen petition, stating that problems were discovered in 42% of the batches that it checked.

Batches tested by the lab were sourced from 22 different companies and significant variation was found between batches, even within a single company. This is the third citizen petition that Valisure has filed in relation to the ongoing nitrosamine situation:

CMDh Practical Guidance For Marketing Authorisation Holders

10 March 2020

The CMDh has updated its Practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines.

Changes include the approach to be taken to nitrosamine risk evaluations and risk assessments during assessment of marketing authorisation applications, including recommendations on the location of the documents within the dossier.

EU Regulatory Roundup: UK Calls For Mutual Recognition Of GMP Certificates In Brexit Negotiation Plan

09 March 2020

Ahead of the Brexit trade deal talks, the British government has called for the mutual recognition of GMP certificates in order to facilitate cross-border trade in medicinal products post-Brexit.

Similar to existing agreements between the EU and other countries, the UK has also called for the mutual recognition of medicinal product batch-testing certificates, agreements on the sharing of confidential information and cooperation in pharmacovigilance.

Other topics discussed in the article below include: the consolidation of the EMA’s human medicines operations into one division that houses three departments focused on scientific evidence generation, the quality and safety of medicines, and committees and quality assurance; Germany’s Federal Institute for Drugs and Medical Devices (BfArM) has suspended some sartan-containing medicines after some manufacturers have failed to minimize the risk of nitrosamine contamination; the MHRA has issued a notice on the risk of lacerations from a particular brand of duodenoscopes; the Spanish Agency of Medicines and Medical Devices (AEMPS) has issued alerts about surgical masks containing false CE marking certificates:

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