Last week’s round-up; 15 – 19 June 2020

Ph.Eur. Supplement 10.3

The EDQM has published the contents of the Ph.Eur. Supplement 10.3. The list includes several new texts, such as the new monograph for testing bacterial endotoxins using recombinant factor C (2.6.32), as well as many revised general chapters and monographs. These new and revised texts will be implemented by 1st January 2021. Several corrected texts are also included in the list and these should be implemented by 31st August 2020. The list also includes texts that will be deleted from the Ph.Eur.

The entire list of contents of Supplement 10.3 may be viewed here: 

New EMA Bioequivalence Guidance for Levothyroxine Tablets and Abiraterone Tablets

The EMA has released the following draft product-specific guidelines: • A new bioequivalence guideline for Levothyroxine tablets 12.5 mcg, 25 mcg, 50 mcg, 75 mcg, 100 mcg (and additional strengths) and 200 mcg. • An updated bioequivalence guideline for Abiraterone tablets, which includes the addition of the 500 mg strength.

These draft guidelines are open for public consultation until 30th September 2020.

EMA, EC and Health Canada Confidentiality Arrangement

EMA, the European Commission and Health Canada signed a confidentiality arrangement in 2007. This was renewed in 2013 and 2020. The most recent changes introduced in 2020 include references to personal data legislation and to ensure the permanent validity of the arrangement.

The full document is available here:

FDA testing methods to detect nitrosamine impurities in Metformin

The FDA has published two analytical methods that regulators and pharmaceutical companies may use to detect nitrosamine impurities in metformin APIs and drug products: • LC-HRMS method: an LC-MS method for the detection of NDMA in metformin drug substance and drug products. • LC-ESI-HRMS method: an LC-HRMS method for the measurement of amounts of eight nitrosamine impurities in metformin drug substance and drug products. Users are required to validate these methods if the resulting data is used to support a quality assessment of the API or drug product or regulatory submissions: 

Global regulators work towards alignment

The International Coalition of Medicines Regulatory Authorities (ICMRA) convened its regular meeting on 12 June 2020 to discuss high-level policy and regulatory approaches in response to COVID-19. They agreed that a clear distinction between exploratory clinical trials and confirmatory studies with investigational or repurposed medicines for treatment of COVID-19 is critical for prioritisation. Regulators also shared concerns about the discontinuation of clinical trials globally and the growing number of underpowered studies that might not generate the robust data required for decision-making. Full details of the output from the meeting can be found here

EDQM companion list of training materials for vaccines

In order to support vaccine developers during the COVID-19 pandemic, the EDQM has made the Ph.Eur. quality standards for vaccines freely accessible through an online database on the EDQM website. Further to this, the EDQM has now also compiled a companion list of training materials related to vaccines. The document is intended for COVID-19 vaccine developers, including universities and small and medium-sized enterprises, with the intention to fast track their understanding of the Ph. Eur. and to help them to apply the relevant texts. The EDQM’s companion list includes hyperlinks to various presentations that were originally given at an EDQM Training Session on Biologicals held in February 2020 and any content of specific interest for vaccine developers is highlighted.

The list is not exhaustive and will be reviewed and updated as required.

EMA and HMA news:  Mandate of the European Innovation Network

EMA and HMA have issued an update to the document describing the mandate of the European Innovation Network (EU-IN), which seeks to coordinate and integrate views of national agency innovation offices and EMA’s Innovation Task Force for the early identification of promising developments, integration in the EU adaptive pathways, facilitate national designation of small and medium enterprises (SMEs) and to investigate the establishment of harmonised criteria for borderline products.

The full mandate can be found here:

Last weeks round-up; 9 – 13 December 2019


In the six years since implementation of the pharmacovigilance legislation over 26,000 potential signals were reviewed, resulting in 453 signals assessed by EMA’s safety committee (PRAC). More than half of the PRAC recommendations resulted in changes to medicine product information supporting the safe and effective use of medicines. The system also proved responsive with recommendations for risk minimisation measures made in as little as five days of a signal being confirmed (median of five months). A recent article describes the process for signal management in place in the EU, and outlines the specific actions to rapidly communicate reliable information on the safety of medicines. The article can be found under this link –


EMA update on metformin diabetes medicines On the 6th December the EMA issued a press release indicating that the levels of NDMA in the affected non-EU metformin medicines are very low and appear to be within or even below the range that people can be exposed to from other sources, including certain foods and water. Patients in the EU should continue taking their metformin medicines as normal. EMA will provide further updates as more information becomes available.