CH: Swissmedic starts pilot phase for paragraph 13 TPA applications in eCTD format

The Swiss drug regulatory agency Swissmedic released an announcement that the agency is about to start it's pilot phase for electronic submission according to paragraph 13 TPA (Swiss Therapeutic Products Act). This recent announcement is on schedule with step 2 of the SIMES project (implementation of electronic submissions in eCTD format).

It is planned that as of July 2010 eCTD applications according to paragraph 13 TPA will be accepted in the course of a pilot program. This pilot phase will last from July to December 2010. For this purpose a corresponding draft  guidance will be available as of June 2010. The guidance will be reworked by the end of the year based on the experience made during the pilot phase.

Therefore, Swissmedic is currently looking for companies that are willing to submit an eCTD of an application according to paragraph 13 TPA during the afore-mentioned period. For pilot submissions no paper copy of the file will be requested.

Detailed information about the requirements that must be fulfilled to take part in the pilot program for paragraph 13 TPA applications in eCTD format as well as contact information is available on the Swissmedic website (see link below).

[Source: Swissmedic website]

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