Last week’s round-up, 18-22 November 2019

By Stephanie Allampalli and Marthese Mifsud

CHMP’s Position on NDMA in Ranitidine

21 November 2019

The CHMP has held discussions on the course of action to be taken within the EU over the presence of the carcinogenic impurity NDMA in some batches of ranitidine medicines.

In order to assess the potential root causes and their effect on the benefit-risk balance of ranitidine-containing medicines, the European Commission has triggered a referral procedure under Article 31 of Directive 2001/83/EC. The EMA has also issued a proposal for a tender to perform a pharmacoepidemiological study to investigate the potential risk of cancer associated with ranitidine.

Even though the CHMP has expressed concerns about the methodology of the study, the CHMP has said that ‘the EMA is welcome to proceed with the tender but CHMP is currently not in a position to formally adopt a recommendation for it.’ In view of this the EMA intends to liaise with the CHMP rapporteurs’ teams to address some of these concerns:

Ph. Eur. Launches Public Consultation on General Chapter 2.4.20. Determination of Elemental Impurities

20 November 2019

The European Pharmacopoeia Commission has launched a public consultation on the newly harmonised standard for elemental impurities testing, general chapter 2.4.20 Determination of elemental impurities.

This revised version of the chapter retains the flexibility of the previous version allowing users to choose any appropriate analytical procedure provided that the procedure is validated according to the text. Harmonisation of Ph.Eur. 2.4.20 also supports the principles of the ICH Q3D Guideline on elemental impurities:

IGBA Calls for Further Regulatory Convergence on Biosimilars

19 November 2019

The International Generic and Biosimilar Medicines Association (IGBA) has called on regulators to increase harmonization on biosimilars, especially with regards to foreign-sourced reference products. Certain countries require bridging studies to be carried out when foreign-sourced reference products are used in biosimilars. Therefore, the general secretary of the IGBA has highlighted the need for a global framework and more regulatory alignment amongst regulators in order to prevent repetition of clinical studies. The IGBA is also working with the WHO in an effort to streamline the requirements on biosimilars and associated clinical trials:

FDA Task Force Recommends Rating System for Drug Manufacturing Quality

18 November 2019

A new FDA report on the root causes and potential solutions for drug shortages proposes a new rating system for pharmaceutical manufacturing quality. Through this system the agency aims to increase buyer recognition and reward of manufacturing quality maturity through “a number of different mechanisms, such as paying higher prices for drugs manufactured at top-rated facilities, requiring a certain quality maturity rating as a condition of contracting, or guaranteeing purchase of a set volume of products from sites achieving a certain maturity rating”:


Image: Test tubes and other recipients in chemistry lab, CC BY 2.0  

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