KNOELL’S ANIMAL HEALTH REGULATORY UPDATE: AUGUST 2023

The EMA has posted the minutes from the CVMP meeting of 13 – 15 June 2023 (Link). Consultations opened at the end of July in relation to various scientific guidelines (some of these guidelines are due to be updated, others are new), with a deadline for responses to most of the consultations at the end of October. Two revised guidelines have been adopted, and EMA have also planned two webinars for Q3 that will be of interest to regulatory professionsals.

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EMA/CVMP

CONSULTATIONS

• Consultation has opened with a draft concept paper on the revision of the guideline on radiopharmaceuticals. Comments are invited until 31st October;
• Consultation has opened for the development of a reflection paper on the availability and characteristics of diagnostic tests to improve the responsible use of antibiotics in animals. Comments are invited until 31st October;
• A concept paper has been published for consultation, on the revision of the guideline on radiopharmaceuticals based on monoclonal antibodies. Comments by 31st October;
• Consultation has opened on a concept paper for the revision of the guideline on demonstration of efficacy of ectoparasiticides. Comments by 31st October;
• A draft guideline on quality data requirements for applications for VMPs other than biologicals intended for limited markets has been published for consultation, with comments invited until January 31st 2024.

Guidelines

• A new guideline has been adopted, on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats;
• A revised CVMP guideline has been adopted describing the information that needs to be submitted about excipients in the context of MAAs for VMPs;
• A revised CVMP guideline has been adopted on stability testing of existing APIs and related finished products.

EVENTS

• EMA will host a webinar on regulatory procedure management for product lifecycle management in IRIS, in the morning of September 15th. The event is most relevant for those working in regulatory affairs and is relevant to human and veterinary medicines;
• EMA will host a webinar for Industry stakeholders on the UPD, regarding product grouping and third country product names. This will take place in the afternoon of 18th September, see the event page.

Administrative and reference

• A list of eligible industry stakeholder organisations has been published by EMA, in accordance with transparency rules;
• Issue 59 of the EMA’s SME newsletter is now available.

HMA/CMDV

• The CMDv dates for 2024 have been revised;
• A revised version of the CMDv guidance document for links to national databases of authorised products was published this month;
• The summary of National Authority fees, terms of payment and addresses was revised and re-issued.