Routine for scientific advice

The Medical Products Agency gives the industry and other interested parties e.g. academic institutions, advice concerning the development of medicinal products based on the applicant’s documentation. Advice may be requested for all medicinal products, irrespective of subsequent choice of procedure for approval.

This information is intended to clarify the process for requesting scientific advice from the Medical Products Agency (MPA).

The MPA and the Dental and Pharmaceutical Benefits Agency (TLV) offer joint scientific advice meetings.

 More information about joint scientific advice

Scope

The scope of the scientific advice meeting is to facilitate an open dialogue concerning the development work. Advice may be requested on matters concerning the preclinical, clinical, statistical, pharmacokinetic, chemical/pharmaceutical documentation and relate to applications for marketing authorization or for clinical testing. The questions put by the applicant may be prospective and concern the future development of a medical product, but may also involve a discussion of results of investigations carried out. However, the MPA does not supply a prior assessment of the documentation with respect to the approval of a medical product for sale.

Request for advice

Procedure

The applicant submits the appropriate form to the MPA. Relevant specified questions must be included on the application form. The request is sent by regular mail or e-mail to the MPA registrar.

Relevant documentation for the request can either be attached or sent separately. The documentation should be submitted no later than three weeks ahead of a planned meeting, if not otherwise agreed.

The background documentation must contain a briefing document of maximum 100 pages including final question list and participants’ list with nationalities in Word-format. This should be submitted in paper (the number of copies will be specified by the MPA).Other relevant documentation, such as references, Investigator’s Brochure etcetera, may be submitted only electronically.

The MPA may provide advice in writing, via a telephone conference or at a face to face meeting.

The MPA appoints a contact person who responds to the applicant within two weeks from receipt of the request for advice together with the specific MPA reference number. The applicant is required to specify the reference number in all contacts regarding the scientific advice meeting. The applicant may request the preferred form of advice.

The MPA is unable to offer scientific advice meetings in July and August due to the summer holiday period. It is possible, though, to submit applications during the summer. However, the turnaround time may be longer than usual.

Due to practical reasons the number of participants should not exceed 8 participants from the applicant.

Written advice

In case of requested written advice, the MPA will send the response within two months from receipt of relevant documentation.

Meeting minutes

The meeting is held at the premises of the MPA. During the meeting, notes are kept by the MPA. Minutes from the applicant may be submitted to the MPA within one month. The Agency will acknowledge the receipt of the minutes and may comment on the content. The minutes cannot be interpreted as a document issued by the MPA, or as an official position of the Agency.

Pre-submission meeting

The company may request a pre-submission meeting if the MPA is appointed rapporteur or co-rapporteur. A pre-submission meeting is an opportunity for the company to present its product, to discuss regulatory matters and cannot contain any scientific questions. The pre-submission meeting is free of charge. The MPA will classify the meeting as a scientific advice, and a fee will be charged, if the application contains scientific questions. The same application form as for scientific advice should be used for pre-submission meetings.

Fees

The Government has decided on the fee for scientific advice (SFS 1993:595), currently SEK 45,000. An invoice will be sent to the applicant after the scientific advice has taken place, with the liability to pay within 30 days.

Advice not liable for a fee

  • Regulatory advice, e.g., choice of procedure, inquiry whether the MPA accepts RMS-ship, given that the proposed discussion does not include simultaneous discussion of the documentation for the application, manufacturing authorization, pharmacovigilance, labelling.  Regulatory Advice from the Medical Products Agency
  • Academic Institutions, e.g., hospitals, universities, researchers not financed by the industry.
  • Advice with reference to assessments in progress.

Consequences of scientific advice

The advice given is not binding, either on the Medical Products Agency or on the company.

EMA scientific advice

The MPA is also participating in scientific advice at EU level through the Scientific Advice Working Party (SAWP) and has the role as co-ordinator for a high number of advice each year. For more information about EMA scientific advice see the European Medicine Agency’s (EMA) homepage:

 Scientific advice and protocol assistance

 

 
 

Contact information

Application form and inquiries in general should be addressed to the MPA registrar.

 

Related information

   
 

Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | phone: +46 18 174600, fax: +46 18 548566 | Contact information