Last week’s round-up, 09-13 December 2019

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud

Nitrosamine risk assessments for all substances for pharmaceutical use?

12 December 2019

The Ph. Eur. Commission has proposed an update to the monograph on Substances for Pharmaceutical Use, to introduce nitrosamine risk assessments for all substances (active substances and excipients), not only those obtained through chemical synthesis but also those from natural sources and products of fermentation.

The draft revised monograph (attached) was published on 11 December 2019. Consultation ends on 31 March 2020.

The consultation deadline for five recently released European Pharmacopeia texts is drawing near.

12 December 2019

The texts include revised general monographs on eye preparations, ear preparations, and liquid preparations for cutaneous application. The chapter on uniformity and accuracy of delivered doses from multidose containers has been revised on the basis of feedback already received, and this revised chapter is available for comment. A new general chapter on particulate contamination: sub-visible particles in non-injectable liquid preparations is also available.

Stakeholders have until 31st December 2019 to submit related comments:

USMCA Drops Biologic Exclusivity Provisions for Mexico and Canada in Final Deal

11 December 2019

The new trade agreement between the US, Mexico and Canada (USMCA) has dropped the originally proposed extended exclusivity provisions of biologicals in Mexico and Canada. This new agreement has had repercussions for the biopharmaceutical industry, as it not only reduces exclusivity but also pulls out other provisions related to patent evergreening and new research exclusivities.

The House Committee on Ways & Means has said that the “House Democrats removed provisions that contribute to high prescription drug prices to preserve Congress’s ability to change US law to improve access to affordable medicines”. While the new agreement has been praised by the generic industry group, the Association for Accessible Medicines, it has also been criticised by the biopharma industry as it reduces the protection of intellectual property (IP) in American biopharmaceutical research and development.

NASEM Committee Calls to Expand Agreements Between Drug Regulators

10 December 2019

The National Academies of Sciences, Engineering and Medicine (NASEM) have called for an increase in unredacted information sharing between global regulators.

NASEM released a report last month, carried out at the request of the FDA, outlining how drug regulators currently share information and offering recommendations for improvement. Within the report, the committee has also called on regulators to expand the scope and substance of current mutual recognition agreements, to encompass matters related to good clinical practice, good laboratory practice, and good pharmacovigilance practice.

The report also recommends that lower-resourced regulatory authorities should consider the risks and benefits of unilateral recognition of decisions taken by trusted regulatory authorities when these may facilitate better public health decision-making:

Stability Testing for Small-Molecule Clinical Trial Materials

10 December 2019

Stability testing of clinical trial materials (CTMs) is essential in every phase of the trial in order to ensure the safety of the patients taking part. Stability testing ensures that the formulation of the medicines administered to patients remains the same throughout the trial. This is essential as the stability of APIs may be affected by various factors, including the production process, nature of the excipients, packaging and other factors.

However, various guidance documents on stability testing of CTMs published by the FDA, EMA and ICH seem to be fragmented and somewhat vague. In this PharmTech article, various key players in the pharmaceutical industry discuss the challenges and various aspects of CTMs stability testing that are encountered due to the differing guidance available. These issues include: confusion regarding the duration and design of stability studies, potential timeline extensions, challenges encountered during method development and validation, and testing of placebos and blinded clinical comparators.

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