Participation of Swissmedic in the Information Sharing Pilot involving the Decentralised Procedure of the European Union

31.07.2014

The International Generic Drug Regulators Pilot (IGDRP) was launched in April 2012 with the objective of enhancing international collaboration in the area of the authorisation of generics. Members of the IGDRP are the medicinal products regulatory authorities of Australia, Brazil, Canada, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore, South Africa, Taiwan, the EU and the EDQM. The WHO has observer status. For further information on the IGDRP, please see the WHO publication in the WHO Drug Information, Vol. 28, No. 1. 2014.¹

At the most recent IGDRP meeting in Taiwan held from 26 to 28 May 2014, the EU has offered the IGDRP members to pilot the DCP as a model for information sharing. A generic drug applicant wishing to market the same generic product (for Swissmedic, a medicinal product with a known active pharmaceutical ingredient, without innovation) in the EU through the DCP and in other jurisdictions that form part of IGDRP, the EU would share the assessment reports generated as part of the DCP in real time with collaborating IGDRP agencies outside the EU.

Within the framework of its international activities and its active participation in the IGDRP since it was founded, Swissmedic is taking part in the information sharing pilot.

The following applications for medicinal products with known active pharmaceutical ingredients without innovation will be considered in the pilot:

• Immediate release, solid oral dosage forms
• Solutions (e.g. oral, parenteral)

The Administrative Ordinance Instructions: Authorisation of human medicinal products with known active pharmaceutical ingredients should be followed.
In addition, the following points should be taken into consideration:

• The application is submitted simultaneously to the authorities in the EU and to Swissmedic
• The EU and Swissmedic will conduct separate assessments
• The Preliminary Assessment Report, the Draft Assessment Report and the Final Assessment Report generated as part of the DCP will be shared with Swissmedic. Swissmedic, on the other hand, will not provide any assessment reports to the EU authorities
• The decision on the product approval is made by Swissmedic based on the national legislation in force.
• The time limits imposed by the Swissmedic approval procedure will be adhered to
• Swissmedic will proceed with the subsequent milestone (List of Questions, preliminary decision, official decision) as soon as the assessment phase is completed, irrespective of the availability of the EU Assessment Report

The pilot is independent of the Article 13, TPA procedure. Art. 5d, VAM is not applicable in this pilot.

Sponsors interested in participation in the pilot are encouraged to complete the corresponding forms (Expression of Interest, EOI) and return them by no later than 26 September 2014.

The completed forms should be forwarded to the CMDh Secretariat
(H-CMDhSecretariat@ema.europa.eu) and to Swissmedic
(networking@swissmedic.ch) at least 8 weeks prior to the intended submission.

In parallel, the Reference Member State (RMS) of the EU DCP and the CMDh member of this member state (please see http://www.hma.eu/352.html) should be informed.

The document EOI_DCP Information Sharing Pilot provides more detailed information on the pilot.

¹http://www.who.int/medicines/publications/druginformation/DI_28-1_Regulatory-Harmonization.pdf