Last week’s round-up;
26 – 30 October 2020

published 2 Nov 2020

New FDA Guidance on Referencing Approved Drug Products in ANDA Submissions

The US FDA has published a ‘Referencing Approved Drug Products in ANDA Submissions Guidance for Industry’. The guidance provides some clarifications to potential applicants who wish to seek approval for generic medicines on how to identify a reference listed drug (RLD), a reference standard, and the basis of submission in an ANDA submission. The FDA also provides recommendations on how applicants can accurately use these terms in an ANDA, how applicants can request FDA designation of an RLD, and how FDA selection of a reference standard may be requested. The recommendations in the document are nonbinding.

EMA’s implementation plan to address nitrosamine impurities

The EMA has released its full plan to implement recommendations to reduce the risk of nitrosamine contamination in medicines. The Agency’s plan specifies the short-, medium- and long-range priorities. The plan is based on the June 2020 “lessons learned” report from the European Medicines Regulatory Network on the problem of pharmaceutical contamination with nitrosamine impurities. It includes 40 separate recommendations and corresponding actions from the report and for each recommendation the plan identifies a lead agency, other involved parties and a timeline. The EMA’s plan also recommends that assessors are appropriately trained to ensure that the recommendations concerned are implemented in the review of MA or variation applications. A detailed question-and-answer document is also in the pipeline within the next 12 months and will provide information about potential sources of nitrosamine impurities, as well as other substances of concern. 

 EMA issues a reflection paper on development of Medicines for use in older populations

The email has issued a new and most interesting reflection paper on the development of Medicines for use in older populations.It is interesting from the perspective that whilst the main audience of the envisaged new guidance is the medicines developers, the concepts may too be of interest to other stakeholders such as physicians, pharmacists and patients because of topics such as patient adherence, medication safety and practical medication problems. Rather than focusing solely on chronological age, it states it is more important to focus on biological age of the patient. Therefore, the paper recommends to take a patient-centric approach to pharmaceutical development as the model approach. In addition, companies are encouraged to seek scientific advice in order to design, from the beginning, a medicine portfolio that takes into account as much as possible, the disease, disease setting and the needs of any patient, including older people with comorbidities and polypharmacy.

The paper in full can be accessed via this link: 

MHRA UK and EU Transition:  new rules for 2021

There are some recent updates on the MHRA site, regarding new assessment routes, procedures for PIPs, conversion of Centrally Authorised Products to GB Marketing Authorisations (as communicated with Marketing Authorisation Holders), and also a change regarding Falsified Medicines Directive. Please note that although MHRA has been publishing some guidance, they have also been busy updating all guidances. However, a number are being held subject to agreement between the parties currently negotiating the final deal between UK and EU. It was due to happen by mid-Oct, which is why they planned a series of webinars on various topics which are being run at present. Indeed, MHRA also plans to tweak the guidances again from questions arising from the various webinars.

A link to the area of interest with the above and other links can be found here

CMDh updates – October 2020

The CMDh has revised the following guidance and forms:

• Revised best practice guides for the processing of Type IA and Type IB notifications in the mutual recognition procedure (tracked).

• Revised examples for acceptable and not acceptable groupings for MRP/DCP products document (tracked). A new example of variations involving changes to related substances specifications that are acceptable as single changes rather than as a grouping is included.

• An updated assessment report template for the repeat use procedure.

• Revised Q&A – Pharmacovigilance Legislation (tracked). Question “2. How should I submit a new RMP or an updated RMP to update my dossier?” has been updated.

• Revision 3 of the EU ASMF number request form, as well as contact points for submitting the request. 


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