AEMPS Scientific Advice Procedure

Last update: 25 February 2014

AEMPS Scientific Advice Procedure

Legal basis

  • Real Decreto 1275/2011, de 16 de septiembre, por el que se crea la Agencia estatal «Agencia Española de Medicamentos y Productos Sanitarios» y se aprueba su Estatuto.
  • Circular 12/2002 de la Agencia Española del Medicamento, instrucciones para la solicitud de asesoramiento científico sobre la calidad, seguridad y eficacia de un medicamento de uso humano o de uso veterinario, durante las etapas de investigación y desarrollo del mismo, para iniciar un procedimiento de reconocimiento mutuo y otro tipo de asesoramientos
  • Ley 10/2013, de 24 de julio, por la que se incorporan al ordenamiento jurídico español las Directivas 2010/84/UE del Parlamento Europeo y del Consejo, de 15 de diciembre de 2010, sobre farmacovigilancia, y 2011/62/UE del Parlamento Europeo y del Consejo, de 8 de junio de 2011, sobre prevención de la entrada de medicamentos falsificados en la cadena de suministro legal, y se modifica la Ley 29/2006, de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios.

Scope

Scientific Advice focuses on development strategies and is prospective in nature. The Spanish Agency for Medicines and Medical Devices (AEMPS) will provide scientific advice on questions concerning the 3 main areas of medicinal products development:

  • Quality
  • Non-clinical/safety
  • Clinical

Additionally, it can also be given on issues related to pharmacovigilance or regulatory requirements.

This procedure should not be aimed at any pre-evaluation of data to support a Marketing Authorization Application.

Type of procedures

There are three different types of scientific advice procedures:

  • Initial scientific advice. Within this category requests are classified according to the applicable fee, depending on the included questions:
    • Questions on (a) quality, non-clinical and clinical development, or (b) quality and clinical development, or (c) non-clinical and clinical development.
    • Questions on (a) clinical development, or (b) quality and non-clinical, or (c) quality and bioequivalence studies for generic medicinal products.
    • Questions on (a) quality, or (b) non-clinical, or (c) bioequivalence studies for generic medicinal products.
  • Follow-up scientific advice. They are defined as any subsequent requests falling within the same therapeutic indication and initial area(s) as the initial request. The requests will be classified following the same criteria than for initial requests with the only difference that the applicable fees are reduced.
  • Pre-submission meetings. The procedure to request these meetings would depend on the medicinal product for which it is submitted:
    • Medicinal products for which a marketing authorization application or a proposal for variation to the terms of the marketing authorisation will be submitted through the centralized procedure and for which a Spanish member of the Committee for Medicinal Products for Human Use (CHMP) had already been appointed as Rapporteur or Co-Rapporteur. The instructions to be followed are detailed in the following document: AEMPS Pre-Submission Guidance for Users of the Centralised Procedure.
    • Medicinal products for which a marketing authorization application or a proposal for variation to the terms of the marketing authorisation will be submitted through decentralised or mutual recognition procedure and for which the AEMPS is or has been appointed as Reference Member State (RMS).

      These presumbission meetings will be organized at the request of the AEMPS or the Company (after agreement with the AEMPS). Payment of fees is not required for this type of meeting.

      The procedure for requesting these meetings as well as the procedure, timelines and documentation needed are the same to those applicable for scientific advice.

    • Medicinal products for which a marketing authorization application will be submitted through national, decentralised, mutual recognition or centralised procedure and for which there is not already appointed RMS or Rapporteur/Co-Rapporteur, as applicable. In these cases the procedure should be in line with the requirements and timelines described in this document for scientific advice.

If a request includes questions which are related only with the paediatric development of a particular medicinal product a specific reduced fee would be applicable.

In addition, those requests that according to the Applicant are not included in any of the categories described above but for which the Applicant requires de formal opinion of the AEMPS, could be submitted to the General Scientific Advice Inbox (ascina@aemps.es) for consideration.

Procedure and timelines

Depending on the submitted questions, the procedure will be AEMPS will decide on the convenience of a written report or a meeting, being the latter the most frequent choice.

The meeting will usually take place at least one month after validation of the procedure depending on the assessors’ availability and also taking into consideration the Applicant’s preferences. They will preferably be face-to-face meetings that will take place at the AEMPS premises and the necessary logistic framework will be provided. They should not last more than 90 minutes and the names of the participants and their position within the Company should be notified in advance (please, limit the number of company staff attending the meeting to 8).

The minutes of the meeting are to be prepared by the applicant within the following 15 days and sent to the AEMPS. These will be reviewed and the Final Scientific Advice Report(1) sent to the Applicant.

In relation to the timetable in both cases, written report or meeting, the final report will be sent to the Applicant in no more than 90 days after validation of the complete set of documents meaning the finalization of the procedure.

Documentation

  • Application form (Annex IA)
  • Letter of intent
  • Questions and applicant’s position (Q&As format)
  • Relevant information about the product concerning the posed questions
  • Previous scientific (advice/assessment) reports from other NCAs
  • Relevant guidelines - UE, ICH, FDA, etc.
  • Bibliographical references
  • Proof of fee payment: http://www.aemps.gob.es/industria/tasas/home.htm (Group VII)

The relevant documentation should be available at least 30 days before the meeting.

The request (1 hard copy + 1 CD, either in Spanish or English) should be sent to the address included below. In those cases where the bibliographical references are lengthy it would be necessary to submit them in electronic format.

Registro central – AEMPS
Att: Asesorías Científicas Nacionales
Edificio 8
C/ Campezo 1
E-28022 Madrid / Spain

For further information in relation to the Scientific Advice procedure at the AEMPS, please do not hesitate to send your request to the General Scientific Advice Inbox: ascina@aemps.es

(1) Please note that the scientific advice given is not legally binding with regard to any future application or change in the conditions of the authorization for the product concerned, neither on the part of AEMPS nor on the Company. The responses given by the AEMPS are based on the questions and supporting documentation submitted by the Applicant, considered in the light of the current state of the art in the relevant scientific fields, and cannot account for future changes and developments in scientific knowledge or regulatory requirements.

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