Round-up, 23 December 2019 – 03 January 2020

By Tessa Fiorini-Cohen, Stephanie Allampalli and Marthese Mifsud


European Paediatric Formulary online

03 January 2020

The EDQM has announced that the European Paediatric Formulary can now be accessed free of charge on a dedicated online platform.

The project, launched by the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission, allows pharmacists and clinicians to prepare paediatric treatments when a licensed alternative is not available.

The platform currently contains four texts, including two general chapters, and the following two monographs: Hydrochlorothiazide 0.5 mg/mL oral solution and Sotalol hydrochloride 20 mg/mL oral solution. Further work is underway and new monographs will be added to the formulary in due course.


Australian reforms to the market authorisation process for generics

02 January 2020

The Australian Therapeutic Goods Administration (TGA) have implemented some changes to the bioequivalence requirements in the marketing authorisation procedure of generic medicines.

In order to establish ‘identicality’ between Australian reference products and overseas reference products, applicants do not need to provide quantitative analysis of the excipients for most solid oral dosage forms and any evidence required may be determined using a new flow chart and checklist.

The TGA has also issued new internationally aligned templates for summarising bioequivalence or biowaiver study data, which may help applicants by reducing the risk of submitting incomplete MAAs.  The following new templates have been issued: Bioequivalence Study Information Form (BSIF), Additional strengths biowaiver template and Biopharmaceutics Classification System (BCS)-based biowaiver template:


Regulators Launch International Sterile Medicines Inspection Pilot

30 December 2019

The EMA has announced the launch of an international pilot program on sterile medicines manufacturer inspections.

The pilot program will last for a minimum of two years and will enable regulators across the EU, US, UK, Australia, Canada and Japan to share information from good manufacturing practice inspections of sterile medicines manufacturing sites.

Participating regulators have committed to coordinate and share their inspection plans with other participating authorities, share inspection outcomes on a monthly basis, and provide inspection reports to other participants when requested. Under the program, participants are also encouraged to carry out joint inspections:


CMDh update on nitrosamine impurities

27 December 2019

An update on requirements related to nitrosamine impurities has been published by the CMDh.

This includes new Q&As on the required approach for new and ongoing marketing authorisation applications, and biological products. The document also details required steps if new information on potential root causes is identified after the initial risk evaluation, and describes the limits that should be applied for nitrosamines based on lifetime and less than lifetime use.

Other Q&As have also been updated, namely those relating to the products that need to be reviewed, the currently identified root causes for the presence of nitrosamines, and how regulators will ensure ongoing dialogue with industry.

Related CMDh practical guidance for marketing authorisation holders of nationally authorised products has also been updated accordingly. The guidance clearly states that the risk evaluation needs to also be carried out for products that are not yet marketed, as well as for radiopharmaceuticals. The guidance details expectations in this regard for new and ongoing marketing authorisation applications:


Ph. Eur. seeks feedback on new general chapter on pyrrolizidine alkaloids

23 December 2019

The European Pharmacopoeia is seeking feedback on a new general chapter on pyrrolizidine alkaloids.

Pyrrolizidine alkaloids are naturally found in plants, and the scope of this new chapter is trace analysis of these compounds in herbal drugs, herbal drug preparations and herbal medicinal products contaminated with other plants. The general chapter describes 28 target pyrrolizidine alkaloids and allows for flexibility in the chosen analytical method, providing it meets the specified validation requirements and involves chromatography coupled with mass spectroscopy.

It also describes an analytical procedure that has shown to be suitable for all 28 alkaloids in a number of matrices. Stakeholders have until 31st March 2020 to submit related comments:


Image: 048 / 365CC BY-SA 2.0

Trackbacks and pingbacks

No trackback or pingback available for this article.