Scientific Advice and Protocol Assistance
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What advice is on offer?
National Regulatory Agencies and the European Medicines Agency (EMEA) will offer advice on a drug development programme on all aspects including Quality, Safety, Efficacy and Regulatory Strategy. Advice on the design of clinical protocols for orphan drugs is offered by the Committee for Orphan Medicinal Products.
Why should I seek advice?
The maxim, 'Early Regulatory input into a programme results in a value-enhanced product' was not coined in vain! A recent comment from an EMEA speaker revealed that of the Marketing Authorisation Applications that were refused, the majority of the applicants (~80%) had NOT sought advice on their development programme. Your level of investment in such programmes is substantial, therefore your strategy should be as sound as possible. Consultation with the Agencies is a valuable asset but needs to be carefully managed to obtain the maximum benefit.
EMEA or National?
EMEA are obligated to provide Scientific Advice as defined in Directive 2001/83/EC (as amended), whether or not the proposed product is eligible for a Centralised Procedure. Seeking advice from National agencies can be important in the identification of a partner country for the Decentralised or Mutual Recognition Procedure who will be most suitable to act as the Reference Member State.
US FDA or Other
Non-EU countries will also provide advice on development programmes, the US Food and Drug Administration (FDA) have had formal procedures for this since 1970 and will provide repeated input at all stages of development. Formal meetings may be arranged between the FDA and sponsors or applicants regarding the development and review of products in human drug applications as defined in various sections of the Federal Food, Drug, and Cosmetic Act. For a global marketing strategy the development programme should reflect universal requirements. Consultation with FDA before application for clinical trial approval should prevent also the imposition of 'clinical hold' decisions.
When to seek advice?
Theoretically at any stage of development but more usually after at least Phase I clinical study, when the full nonclinical evaluation has yet to be completed, Quality 'crunch points' may have arisen and plans for the Phases II and III studies are being drawn up.
How do I to apply?
There are formal procedures to approach agencies. Requests to the EMEA for Scientific Advice have to fit within the published schedule of meetings. Akos can assist you with this to ensure the approach is satisfactory and that greatest benefit is obtained.
Documents
Documentation explaining the proposed development programme and listing the questions on which advice is sought have to be submitted in the specified format according to the agency's published timelines. The usefulness of the advice given will be dependent upon the quality of the data presented. Akos can help in getting this right.
Fees
There is a difference around Europe in the fees for consultation, although the US FDA does not charge. EMEA will offer a reduction in fees to Small and Medium Enterprise (SME) companies and for protocol assistance with orphan drugs or paediatric studies.
How can Akos help?
Akos has considerable experience of Scientific Advice and Protocol Assistance meetings with most EU competent authorities. We can provide guidance and assistance in requesting the meeting, drafting the questions, preparing the documentation and presentations (including 'rehearsals' and mock meetings), attending (and if necessary, leading) the meeting and writing up the minutes afterwards.
To discuss your regulatory questions with Akos please contact us:
Tel: +44 (0)1582 766 339
Email: regulatory@akos.co.uk