Applications According to Paragraph 13 TPA: eCTD Pilot Submissions

05.06.10 - In the context of the SIMES project (implementation of electronic submissions in eCTD format) Swissmedic is working on step 2. It is planned that as of July 2010 electronic applications according to paragraph 13 TPA will be accepted. Since the technical implementation of this application type is not straightforward applications according to paragraph 13 TPA will be possible in a first step only as pilot submissions. The pilot phase will last from July to December 2010. A draft version of guidance for submission of electronic applications according to paragraph 13 TPA will be available on Swissmedic's eSubmission Website as of June 2010. It is Swissmedic`s intention to test the guidance for practicability by the help of a series of pilot submissions. Based on the results of the pilot submissions, the guidance will be reworked and a final version will be published later this year.

The participation in a pilot submission gives the company the opportunity to gather initial experiences with electronic submissions for applications according to paragraph 13 TPA and to prepare the life cycle management of the product at an early stage. The company will receive a feedback concerning the experience of Swissmedic with the eCTD submission.

For pilot submissions no paper copy of the file will be requested.

Ideally, the pilot submission should fulfil the following requirements:

• The application should be one of the following submission types:
  New applications and major variations, incl. NAS: New Active Substance, NGF: New Dosage Form, NKO: New Combination of Active Substances, BWS: Known Active Substance, GEN: Generic, IE: New Indication, NDE: New Dosage Recommendation, NDO: New Dosage Strength, New Route of Administration
• The eCTD submission should be compliant with the Swiss Module 1 Specification for eCTD, v1.0.1 or v1.1.
• The submission should meet the criteria of Ordinance on Medicinal products (VAM), paragraph 5a - 5d and the administrative ordinance (Verwaltungsverordnung, not yet final).
• The submission should follow the requirements of the Draft Guidance for Electronic Applications According Paragraph 13 TPA, which will be published in June

It should be noted that the deadlines for processing and reviewing a pilot submission are the same as those currently specified for a paper submission.

Companies interested in an eCTD pilot submission of an application according to paragraph 13 TPA please contact Swissmedic at the following address:

Swissmedic - Swiss Agency for Therapeutic Products
Support Marketing Authorisation - eSubmission
Hallerstrasse 7
P.O. Box
CH-3000 Berne 9
Switzerland
e-mail: esubmission@swissmedic.ch

Swissmedic will only be able to consider a limited number of pilot submissions. Swissmedic will contact interested companies to discuss the deadlines and suitability of the submissions.