Provision of scientific advice

1.      What is scientific advice

State Institute for Drug Control (SIDC) offers to companies the possibility to obtain scientific advice concerning development and licensing of medicinal products for use in humans. This advice focuses on development strategies rather than pre-evaluation of data to be submitted supporting any future application for marketing authorization. It is limited to scientific issues, not the regulatory aspects.

Companies seeking scientific advice must be aware that any advice given is not legally binding with regard to any future marketing authorization application of the product concerned. The advice given is based on the questions and documentation submitted by the applicant and does not reflect future developments in the state-of-the-art, or future changes in applicable legislation. It is not the role of SIDC to substitute the industry's responsibility for the development of their product. Scientific advice in nature can be adopted or rejected.

2.      Scope of scientific advice

Scientific advice can be requested during the initial development of the medicinal product (before submission of the Marketing Authorisation Application) but also during post-authorisation phase. Advice focuses on development strategies rather than pre-evaluation of data to support a Marketing Authorisation Application.

Scientific advice can be requested whether or not existing guidelines are in place. In case where company chooses to deviate from guidance available, it is particularly important for companies to seek scientific advice from SIDC. 

Scientific advice can be given on questions concerning issues relating to:

• quality (manufacturing, chemical, pharmaceutical and biological testing),
• non-clinical aspects (toxicological and pharmacological tests),
• clinical aspects (studies in human subjects in either patients or healthy volunteers, including clinical pharmacological trials designed to determine the efficacy and safety of the product for pre- or post-authorisation activities and bioequivalence studies),
• pharmacovigilance plans (pre-authorisation/post-authorisation phase) and risk-management programs,
• interpretation and implementation of EU guidelines.

The questions should be prospectiveand concern the future development of (a) medicinal product(s).

3.      Application

The complete formal request for scientific advice includes Application form for scientific advice, list of questions and background information concerning advice sought.

Application form for scientific advice should be send by email to SIDC in advance. It includes the description of the product, the intended indication, the scope and the justification of the advice being sought. Draft of the proposed questions should also be attached. If the application is accepted, a date of meeting will be set. Date selected will always be as soon as is mutually agreeable, however, companies are advised to contact SIDC well in advance (approx. 2 months) of their preferred meeting dates.

Following agreement by SIDC to provide scientific advice, the complete request (final list of questions with background documentation) should be delivered to SIDC no less than 1 month before the agreed date of the meeting. One electronic copy of the full documentation should be submitted.

4.      List of questions and documentation

The questions posed to SIDC by the applicant have to be as precise and clear as possible. Only questions which have been put forward in the list are subject of the advice procedure. The company's position and justification, together with cross references to the relevant documentation should follow each question.

In addition to the exact list of questions the applicant is requested to provide an up-to-date documentation that is tailored for the list of questions. This may include background information on the subject of advice, specific problems pertaining to the request, information relating to the questions (e.g. relevant study protocols), relevant guidelines, content of previous scientific advice received. The extend of the appendices should be limited to essential information.

5.      Meeting

At least 10 days prior to meeting date, company is requested to submit a list of those who are to attend the meeting. It should be also clarified, whether the discussion will be held in Slovak or in English. SIDC will select experts in the field, who will review the documentation submitted by company prior to meeting. The maximum duration of the meeting is 2 hours.

The company may wish to make a brief presentation of the issues surrounding each question; however, this should be kept as short as possible (10-15 minutes) to allow maximum time for discussion. Only in exceptional circumstances should any new information, not previously presented in the submitted documentation, be presented. The list of questions is discussed after the presentation.

The company should take notes of the meeting and a copy of these should be received by SIDC within 10 days after the meeting. These notes will be for information only: the final advice should be taken as written in the SIDC final advice letter, not the company's notes. The SIDC answers to the applicant's questions will be sent in writing within 30 days after the meeting. 

6.      Written Advice

After meeting with company and receipt of company's notes, a letter will be prepared giving the answers to each question. The advice will answer only questions submitted in list of questions. The final scientific advice letter will be send to company within 30 days  of the meeting. In general, it should be remembered that the written advice reflects the respective scientific state-of-the-art at the time of the discussion. More recent developments that can become known later are thus not reflected but do still have to be considered in any case.

7.      Fees

Following fees are applicable:

Partial scientific advice:

Partial scientific advice:

Multidisciplinary scientific advice:

8.      Contact for further information

For electronic submission of application, as well as for questions related to the procedure of the requested advice, please contact Dr. Jana Klimasová, telephone number +421 2 50 70 1268, email address jana.klimasova@sukl.sk.

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