Last week’s round-up, 23 – 27 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud


EU-China Working Group to Address API Manufacturing Concerns

27 March 2020

China’s National Medical Products Administration (NMPA) will be working with the European Commission’s DG Sante, the European Medicines Agency (EMA) and others to conduct a gap analysis between the Chinese and EU regulatory systems for APIs.

This working group was created due to concerns over the quality of APIs produced in China following the discovery of nitrosamine contamination of medicines containing valsartan and ranitidine. The aim of this collaboration is to ensure the GMP compliance of APIs that are imported from China.

The European Commission has also approached the FDA to participate in a project for a joint training plan for Chinese and Indian inspectors of API manufacturing sites. The Commission also plans to help align other non-EU countries with EU standards and to assess their GMP systems, as well as explore the possibility for production of APIs in Europe.

(These plans were drawn up before the Covid-19 pandemic, and it is not yet known how they will be affected.)

FDA Finalizes Guidance on Competitive Generic Therapies

26 March 2020

The FDA has finalized its guidance on its designation process and criteria for competitive generic therapies (CGTs), in order to strengthen generic drug competition in the United States.

The document mirrors the draft version released last year and includes several clarifications about the CGT process and its exclusivity provisions. Some of the clarifications in the final guidance include:

  • Individual applicants should request CGT designation for each individual application.
  • Although the development of an application with CGT designation may be expedited, a shorter review time is not guaranteed.
  • Both complex and non-complex generic drugs may qualify for pre-ANDA meetings on a case-by-case basis. These meetings are meant to expedite CGT designation application development, however, the meetings themselves may not necessarily be expedited.
  • Updated terminology in the final guidance “to further delineate 180-day patent exclusivity from 180-day CGT exclusivity” and editorial changes to “clarify the operation of 180-day CGT exclusivity and forfeiture.”

Nitrosamines deadline postponed

26 March 2020

Yesterday evening, the European medicines regulatory network agreed to extend the deadline to complete step 1 (risk evaluation) to 1 October 2020. Further information is expected on Friday 27 March 2020.

The extension follows reports of the challenges encountered in meeting the original deadline of 26 March 2020, and the impact of the severe restrictions in place to combat the COVID-19 pandemic.

Marketing authorisation holders are encouraged to submit the outcome of step 1 before 1 October 2020 if they complete the risk evaluation or identify a risk in their products.

Competent authorities should be informed as soon as possible if tests confirm the presence of nitrosamine, irrespective of the amount detected. They should also assess the immediate risk to patients and take appropriate action to avoid or minimise the exposure of patients to nitrosamines.

Newly discovered ‘magic methyl’ reaction could turbocharge the potency of some drugs

25 March 2020

Researchers in the United States have discovered a “magic methylation” reaction which may be used to increase the potency of certain pharmaceutical products. Increasing the potency of medicines may allow for the administration of lower doses, thus, improving patient safety and reducing side-effects.

This “dream reaction” involves the use of an enzyme-like manganese-based catalyst that, together with other reagents, can selectively target specific bonds within the drug molecule and insert methyl groups. These additional methyl groups increase potency by allowing some drug molecules to interact more easily with their biological targets.

Targeted stakeholders’ consultation on Annex 21

24 March 2020

The EC has published a draft version of the new Annex 21 to Eudralex Volume 4, which summarises GMP requirements related to importation of medicinal products.

The Annex sets out the principles and guidelines of GMP requirements applicable to manufacturing and importation authorisation (MIA) holders that import medicinal products through EEA borders from external countries. It applies to both human and veterinary products, and outlines requirements such as Product Quality Reviews (PQRs), associated batch documentation and stability testing. Comments on the draft are invited until June 2020:

EMA Offers Guidance on Conducting Trials During the COVID-19 Pandemic

23 March 2020

The EMA has released guidance for the biopharmaceutical industry on conducting clinical trials during the current COVID-19 pandemic. The document also contains specific advice on clinical trials for possible COVID-19 treatments.

The EMA has advised on certain measures that companies may take, such as the use of phone or video to conduct patient visits, the temporary halt of a whole trial or some trial sites, the suspension or reduction in the recruitment of new trial participants, the extension of the duration of the trial or the postponement of trials or activation of additional sites.

With regards to trials for new treatments for COVID-19, the EMA has advised that sponsors should obtain advice on alternative procedures for obtaining consent from patients, as physical consent given by COVID-19 patients would not be able to leave the isolation room.

Additional advice will be released as the situation evolves, and further information on the current EMA guidance may be obtained from:


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