National Scientific Advice
National Scientific Advice
- Real Decreto 1275/2011, de 16 de septiembre, creating the State Agency “Agencia Española de Medicamentos y Productos Sanitarios” and approving its Statute.
- Ley 10/2013, de 24 de julio, which transposes into Spanish law Directives 2010/84/EU of the European Parliament and of the Council of 15 December 2010 on pharmacovigilance and 2011/62/EU of the European Parliament and of the Council of 8 June 2011 on the prevention of the entry of falsified medicinal products into the legal suply chain, and amends Law 29/2006 of 26 July 2006 on guarantees and rational use of medicinal products and medical devices.
- Ley 38/2022, de 27 de diciembre, for the establishment of temporary energy taxes and taxes on credit institutions and financial credit establishments and creating the temporary solidarity tax on large fortunes, and amending certain tax regulations.
The objective of the scientific/regulatory Advice (SA) procedure for medicinal products for human use is to provide prospective advice on the clinical development of medicinal products. The Spanish Agency of Medicines and Medical Devices (AEMPS) will provide answers to specific questions related to the following aspects:
It applies to medicinal products that will be subject to a marketing authorization application by national, decentralized, mutual recognition or centralized procedure and for which the Reference Member State (RME) or Rapporteur and Co-rapporteur, depending on the case, have not yet been assigned.
The scientific/regulatory advice procedure does not constitute a pre-assessment of the documentation of the medicinal product that may be subject to an application of a marketing authorization.
When to request a National Scientific Advice?
- When the applicant does not find answers to their questions in the various current guidelines or in the pharmacopoeial monographs.
- Guidelines under review or in draft form.
- Solutions to specific problems, innovative solutions.
- In those cases in which the applicant decides to deviate from the existing recommendations, providing the justified cause of this deviation.
Types of National Scientific Advices
In writing or by TC/meeting. And referring to the type of request they could be differentiated in:
- Initial advice:
From June 28, 2023 the Ley 38/2022, de 27 de diciembre, for the establishment of temporary energy levies and of credit institutions and financial credit establishments and which creates the temporary solidarity tax on large fortunes, and modifies certain tax regulations, will enter into force, in which the advices are classified as follows:
- National scientific/regulatory advice for medicinal products for human use that includes a specific issue. Single Advice. Refers to a question on a specific topic involving a single Division within the same Department. This question may have sub-headings as long as they are clarifying and the above requirements are met.
- National scientific/regulatory advice for medicines for human use that includes multiple issues. Complex Advice. May include multiple issues affecting one or more Divisions within the same Department or different Departments.
- National scientific/regulatory advice for generic medicinal products for human use.
- Follow-up advice:. It is define as any request for an advice for a medicinal product in relation to the same indication and areas that have been requested previously. It must be requested within the 12 months after the initial request (the initial date will be the reception of the final report of the first advice).
- Pre-submission meetings. The procedure to be followed for the request of this type of meetings varies depending on the medicinal product to which it refers:
- Medicines that are going to be subject of a marketing authorization application or a variation in the authorization conditions for which a representative of the AEMPS in the Committee for Medicinal Products for Human Use (CHMP) has been designated as Rapporteur or Co-Rapporteur. The instructions for the request of this type of meeting are those detailed in the: Procedimiento centralizado para la solicitud y celebración de Reuniones previas a la solicitud de registro.
- Medicines that are going to be subject of a marketing authorization application or a variation in the authorisation conditions by a mutual recognition or decentralised procedure in which the AEMPS is or has accepted to be a Reference Member State (RME). The “pre-submission” meetings of procedures in which Spain acts as RME will not require any fee and it will be organised at the request of the AEMPS or the Company, requiring in the latter case the prior approval of the AEMPS. The request of this type of meeting will be followed the same instructions as for the Initial advice (see above).
All those queries that do not fit into any of the above mentioned categories and for which the formal opinion of the Agency is required, should be sent to the institutional mailbox of the Scientific Advices (firstname.lastname@example.org) for consideration.
Procedure and schedule
Request from the National Scientific Advice
Request of the National Scientific/Regulatory Advice by the applicant by sending the following documentation to email@example.com:
- Application Form (Anexo IA) (English version – Annex IA)
- Justification of the advice’s request
- Questions and justified position of the applicant (question-answer format)
Validation and acceptance of the application phase (10 days)
After submitting the request of the Scientific/Regulatory Advice by the applicant the National Scientific Advice Unit (through the following mailbox (firstname.lastname@example.org) will evaluate the request and confirm the acceptance or not of the advice.
If the acceptance of the advice is confirmed by the National Scientific Advisory Unit (email@example.com) the applicant shall send the following documents:
- Relevant product information available and related to questions
- Previous scientific reports issued by an EU or international authority
- Applicable recommendations (EU, ICH, FDA, etc.)
- Bibliographic references used to elaborate the Briefing Document
- Proof of payment of the fee (Enlace a tasas – Asesorías Científicas Nacionales).
The applicant should not apply for this next step without having obtained a positive response from the AEMPS.
These documents must be submitted, at least 30 days prior to the meeting by email or Eudralink to firstname.lastname@example.org
Depending on the issues raised, the AEMPS will decide which of the two types of procedure is more convenient in each case, written report or by TC/meeting. The date of the meeting will be decided considering the dates proposed by the applicant and taking into account the availability of the assessors.
The applicant shall send one week before the TC/meeting the power point presentation to be used during the meeting together with the name of the attendees and their position within the Company.
TC or face-to-face advice will have a maximum duration of one hour and a half.
Written Evaluation Phase (90 days)
In the case of a written report, the final report should be expected no later than 90 calendar days after the validation of the application.
If the AEMPS proposes to carry out the assessment by written procedure and after receiving the final report, the applicant would have any doubts, clarifications will be sent either in writing or by carrying a TC/meeting.
Post TC/Meeting Phase:
The applicant shall prepare minutes of the meeting to be sent to the AEMPS within a maximum of 15 calendar days after the meeting or TC. The AEMPS will review the minutes received and prepare the final report, during the following month after the reception of the minutes. This final report will be sent to the applicant together with the official letter signed by the head of the department of Medicines for Human Use.
Post National Scientific Advice Phase
In both cases the receipt of the final report will imply the end of the procedure. In general, no further allegations or additional questions will be admitted.
The scientific/regulatory advice provided by the AEMPS is not binding and should not be considered as a premonitory decision or recommendation that the AEMPS may give in relation to any potential application for marketing authorization or variation of the conditions of the authorization that may be submitted in the future for the medicinal product that is the subject of the advice. Likewise, it should be taken into account that the AEMPS’ answers to the specific questions asked, and based on the documentation provided by the Company at the time of the application, should be considered in the scientific context (“state of the art”) of the moment in which they are provided, without prejudice to the advances in knowledge or regulatory requirements that may take place at a later date.