Last week’s round-up, 24-28 February 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud


European Pharmacopoeia updates testing for particulate contamination in pharmaceutical preparations

28 February 2020

The European Pharmacopoeia Commission has updated testing for particulate contamination in pharmaceutical preparations.

General chapter 2.9.19. Particulate contamination: sub-visible particles, has been revised in order to supplement the Pharmacopoeial Discussion Group harmonised text, with alternative local requirements applicable to biological parenteral preparations.

A new, non-mandatory general chapter 5.17.2. Recommendations on testing of particulate contamination: visible particles, has also been released. This new chapter provides information on visual inspection and control of visible particles in liquid preparations, which applies to any testing carried out according to general chapter 2.9.20. Particulate contamination: visible particles.

These updates will be published in Ph.Eur. Supplement 10.3 and will become effective on 1st January 2021.

FDA Finalizes ‘Biological Product’ Definition Ahead of BPCIA Transition

27 February 2020

The US FDA has issued a final rule amending its definition of “biological product” to include a new meaning for the term “protein”. Through this new rule the term “protein” means “any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size”.

Therefore, the previously excluded chemically synthesized polypeptides are now included in the definition of “protein”.

This means that as of 23rd March 2020 about 100 products (including insulin and growth hormone) that have been approved under new drug applications (NDAs) will have to transition to biologic license applications.

The FDA has said that “this transition will open new pathways for manufacturers to bring biosimilar and interchangeable versions of insulin and other transitioning products to market, facilitating greater competition in the marketplace”.

European Commission publishes titanium dioxide classification26 February 2020

26 February 2020

The European Commission (EC) has classified titanium dioxide as a category 2 suspected carcinogen by inhalation under EU Regulation (EC) No 1272/2008, which will come into full force on the 9th September 2021.

Titanium dioxide is widely used in pharmaceuticals as well as other products such as paints, food, textiles, cosmetics and suncare products. As per the new requirements, powdered products containing 1% or more of titanium dioxide with aerodynamic diameter of 10µm or less, should contain cancer warnings on their labels. Other products containing more than 1% of the substance should contain specific warning statements and labels.

This new regulation has been criticized by the industry, and the Titanium Dioxide Manufacturers Association (TDMA) has said that it will “attempt to address ambiguities created by the text”.

The EMA has released a number of updates.

25 February 2020

New Q&A has been published on the use of peptones in the manufacture of active substances. This states that peptone is considered a critical raw material and its origin and source must be included in relevant dossiers. Fish peptone involves additional considerations due to potential contamination with histamine.

A new document on electronic product information (ePI) for human medicines in the EU has been published. The document outlines key principles for the development and use of ePI, how ePI will comply with the existing legislative framework, and how it will be implemented and harmonized across the EU.

A new draft of the public statement on the use of herbal medicinal products containing estragole has been published (second draft revision 1). This follows stakeholder feedback and working party re-discussion after publication of the first draft. The second draft is open for public consultation until 15 May 2020.

The EMA has also stated that the ICH M9 guideline on biopharmaceutics classification system-based biowaivers will come into effect on 30 July 2020. This guideline may help avoid unnecessary in vivo bioequivalence studies:

Second targeted stakeholders’ consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4

24 February 2020

A second targeted stakeholders’ consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of Eudralex volume 4, will be held between 20th February 2020 and 20th May 2020.

Through this targeted consultation, the European Commission (EC) aims to collect experience from the different sectors on certain steps in the manufacturing of sterile products, in order to introduce the principles of Quality Risk Management, thus, allowing for the inclusion of new technologies and innovative processes. The EC also aims to restructure Annex 1 to give it a more logical flow and to introduce new sections as well as the addition of further detail to previous sections to provide more clarity.


Image: WHEATON ampules, CC BY-ND 2.0

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