Last week’s round-up;
28 September – 02 October 2020

published 5 Oct 2020

Revised Ph. Eur. dosage form monographs on patches and medicated plasters

The Ph. Eur. commission has adopted the following revised dosage form monographs on transdermal patches, cutaneous patches and medicated plasters:

    • A new version of Patches (1011) – The monograph now covers both cutaneous and transdermal patches since they have similar manufacturing and quality control requirements.
    • General chapter 2.9.4 Dissolution test for transdermal patches – This has been revised to ensure that it applies to both cutaneous and transdermal patches.
    • A new Plasters, medicated (3032) monograph.


The revised chapters will be published in Ph. Eur. Supplement 10.5 by the 1st January 2021 and should be implemented by the 1st July 2021.

EU CTFG Contraception Guidance updated on 21 September 2020

The EU Clinical Trials Facilitation and Coordination Group Recommendations related to contraception and pregnancy testing in clinical trials was updated to Version 1.1 on 21 September 2020. The changes are as follows:

After the relevant systemic exposure to the medicinal product has ended for exposure to other types of genotoxicants than aneugenic compounds, the duration for applying highly effective contraception measures for women of childbearing potential, has been extended from 1 month to 6 months (one folliculogenesis cycle). The need for informing participants to seek advice about donation and cryopreservation of germ cells in line with this guidance prior treatment if applicable, has been added to the section on the need for sexual counseling of study subjects, e.g. in adolescents, which should be reflected in the protocol.

The new guidance can be found at:

EMA:  Workshop on support for Orphan Medicines Development on 9th Nov 2020.

EMA has announced an upcoming virtual workshop which aims to encourage early and efficient dialogue with the regulators for support with medicines development in rare diseases. The existing processes like orphan designation, protocol assistance and PRIME scheme will be highlighted and explained in the context of early product development strategy. There will be scope too for the sharing of views on early medicines development.​

Further information, including an agenda can be found here:

CMDh meeting report – September 2020

A report from the CMDh meeting held on the 15th-16th September 2020 has been published. Some of the topics covered during the meeting include:

    • The endorsing of the use of dexamethasone in COVID-19 patients on oxygen or mechanical ventilation by the EMA.
    • The implementation deadline of the updated excipients guideline.
    • A minor update of the Practical Guidance for MAHs of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) referral on nitrosamines and an update on nitrosamines in medicines containing metformin was also discussed.
    • Brexit.
    • CMDh positions following PSUSA procedures for nationally authorised products only.
    • MRP/DCP statistics in the first semester of 2020.
    • The adoption of an updated guidance document with the timetables for requests for recommendations on the classification of unforeseen variations by national competent authorities in 2021, and an updated guidance document with the timetables for MRP/DCP applications referred to the CMDh for the 60-days referral procedure in 2021.


The full list of topics discussed during the meeting may be viewed at the following link :

FDA issues cannabidiol bioequivalence guidance for generics

The FDA has released draft product-specific bioequivalence guidance for generic cannabidiol oral solution. The guidance follows the approval of cannabidiol oral solution to treat seizures associated with two rare and serious types of childhood epilepsy and to treat a third seizure condition, tuberous sclerosis complex. The guidance states that generic cannabidiol oral solution 100mg/mL should not contain more than 0.10% tetrahydrocannabinol by weight, and it must have “the same active drug ingredient in the same concentration and dosage form as the reference listed drug” in order to qualify for a biowaiver. The draft guidance is open for public consultation for 60 days following its publication in the Federal Register on the 22nd September 2020.

More information on the contents of the guidance document may be viewed here:

Ph. Eur. monographs for public consultation

Two draft monographs have been published in Pharmeuropa 32(4) and are available for comment until December 31, 2020:

    • A new draft monograph on implementation of pharmacopoeial procedures. This document provides guidance on setting up an approach for implementation of analytical procedures found in Ph. Eur. monographs.
    • A revised monograph on rectal preparations (tracked document).

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