How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.

Overview

You can ask for scientific advice from the Medicines and Healthcare products Regulatory Agency (MHRA) at any stage of the initial development of your medicine, before you have submitted your application for a marketing authorisation (MA) (product licence) and during the pre-submission period for a variation to an existing MA.

Meetings can also be held with the MHRA to discuss:

  • pharmacovigilance
  • advertising
  • proposals to change labelling or package leaflets
  • post-authorisation regulatory advice relating to a product range

You can request a broader scope scientific advice. This would cover broader issues and would not relate to only 1 development programme or product.

You can also have a joint meeting with MHRA and National Institute for Clinical Excellence (NICE).

Scientific advice given by MHRA is not legally binding for any future application of the product discussed, either on the part of MHRA or the company. Advice can’t be taken as indicative of any future agreed position.

MHRA’s answers are based on the submitted questions and documentation and cannot account for future changes and developments in scientific knowledge or regulatory requirements.

Types of advice

The questions you ask MHRA have to be as precise and clear as possible.

The questions should address specific scientific issues on:

  • quality aspects (eg the chemical, pharmaceutical and biological testing necessary to demonstrate the quality of a medicinal product)
  • non-clinical aspects (eg the toxicological and pharmacological testing necessary to demonstrate the safety of a medicinal product)
  • clinical aspects (eg endpoints, trial duration, target population, choice of comparator etc)
  • pharmacovigilance plans and post-authorisation safety study protocols
  • an application for a variation or renewal
  • a referral pursuant of article 30, 31 of the 2001 directive
  • a procedure referred to in article 13 of the 2008 directive
  • advice before publishing advertising for a medicinal product
  • changes to labelling of packaging leaflets for medicinal products or a product range

We prefer that the questions are prospective and concern the future development of a medicinal product.

Broader scope meetings

A broader scope meeting is not a product-specific request. Examples include:

  • general approaches to product development
  • overall product development plans where there are very broad issues that may go beyond what can be discussed at a routine scientific advice meeting
  • complex issues of drug/device combination products
  • choice (including relative pros and cons) of study endpoints in particular indications
  • practical issues of study design, management and analysis
  • risk management plans and other post-licensing aspects
  • legal reclassification of products from prescription-only medicine (POM) to pharmacy (P) medicine or from P to general sales list (GSL)

We will still need some briefing material for broader scope meetings before the meeting and a general idea of the sorts of issues/questions the sponsor(s) wish to discuss, but the meeting will be much less structured than typical scientific advice or pharmacovigilance advice meetings.

It may be appropriate for the sponsor(s) to give an extended presentation and then there can be a discussion around the issues raised. Meetings will still be planned for up to 90 minutes.

These meetings may include a variety of contributors including external experts and lay or patient representatives. Either or both parties can invite participants. The overall composition of the meeting will be by mutual agreement.

MHRA will charge a fee for broader scope meetings.

As these meetings are more wide-ranging and more speculative, MHRA will not give written advice after the meeting.

These meetings are requested in the same way as standard scientific advice meetings.

Meetings with MHRA and NICE

You can choose to ask for a joint scientific advice meeting with the MHRA and National Institute for Healthcare and Excellence (NICE).

At these meetings you will be able to discuss clinical study design that can satisfy regulatory and NICE requirements. You can also get optional input from the Clinical Practice Research Datalink (CPRD).

Following the meeting, MHRA and NICE will produce separate advice documents to answer the respective questions raised.

Ask for scientific advice

Submit the scientific advice form to scientific_advice@mhra.gsi.gov.uk.

On the form you should include:

  • therapeutic area
  • scope of advice being sought
  • number of company staff expected to attend (note that for a meeting with the MHRA Division of Vigilance and Risk Management of Medicines (VRMM) the company attendees should be limited to 4)
  • preferred meeting dates and dates to avoid
  • a draft list of the proposed questions

A mutually-agreed date will then be set. The final briefing document including all the documents listed below should be delivered to MHRA no less than 10 working days before the date of the meeting.

Documents

You should submit 1 electronic copy of the briefing document, including:

  • the final proposed questions together with your position on each question in Word format
  • an electronic copy of any presentation to be given at the meeting
  • any appendices
  • labelling and leaflet artwork examples if the meeting is about changes to labelling and leaflets for a product or range of products

The appendices, if relevant, can include:

  • background information
  • information relating to the questions (eg relevant study protocols)
  • content of previous scientific advice received (national EU authorities, other relevant international authorities)
  • relevant guidelines (other than Committee for Medicinal Products for Human Use (CHMP) guidance documents)

The appendices should be limited to essential information. Extensive information, in excess of that specified in relevant summaries in the Common Technical Document, should not be included.

We will tell you how many paper copies of the briefing document and any presentations should be submitted.

The meeting

We prefer to have face-to-face meetings but video conferencing may be arranged in exceptional circumstances. Telephone and teleconference meetings are generally not considered satisfactory to discuss complex scientific and regulatory issues.

MHRA staff will have reviewed your documentation before the meeting and will either have provisional advice or further questions and clarification for the meeting.

You can give a brief presentation but this should be kept as short as possible (usually only 10 to 15 minutes) to allow maximum time for discussion. A brief presentation of the issues (and perhaps controversies) surrounding each question may be helpful to begin the discussion. Only in exceptional circumstances should any information not in the briefing document be presented.

The meeting will normally last no more than 90 minutes.

You should take notes of the meeting.

After the meeting

We will send the answers to your questions within 30 working days of the meeting.

You should send us your notes of the meeting within 15 working days of the meeting. These notes will be for information only and will not be commented on. The final advice will be provided in the MHRA advice letter.

You can ask us to clarify the advice we give. This will be done by email or teleconference. This clarification will not cover the impact of the advice on other aspects of your development plan or on other development strategies you may consider in the light of the advice received.

Subsequent meetings and follow-up meetings will be charged at the same rate as the initial meeting (subject to the scope of the advice requested).

The advice provided is without prejudice to applicable legislation relating to particulars and documents which should be submitted in support of any marketing authorisation (or other) application; it is also without prejudice to any intellectual property rights to third parties.

Fees

Fees for scientific advice.

Meetings requested by MHRA or covered by agreed waivers will not be charged.

You will be invoiced for your scientific advice after your meeting.

Contact

nathalie.gilmore@mhra.gsi.gov.uk, 020 3080 6172

susan.delaney@mhra.gsi.gov.uk, 020 3080 6476