ICH Guideline Q12: Implementation in Switzerland

Swissmedic is adopting the temporary restrictions issued by the EMA as of 1.04.2020


The ICH Guideline Q12 on the subject of "Technical and regulatory considerations for pharmaceutical lifecycle management" was approved on 21 November 2019 by the ICH Steering Committee under Step 4. As a result of this approval, this harmonised guideline applies within the ICH regions and Switzerland and, in accordance with the defined requirements, essentially reflects the current state of science and technology (see Swissmedic Journal 05/2006, p. 504).

In March 2020, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) referred, in publications on the EMA website1, to temporary restrictions on the full adoption of this guideline2,3,4.

Specifically, these restrictions concern the definitions of the terms "established conditions" and the "PLCM" (Product Life Cycle Management) document. The EMA states that the definition of the established conditions and the associated application types currently have to follow the requirements of the EU Variations Guideline. It also states that a "PLCM document" is not currently recognised in the EU.

Following the entry into force of the revised Therapeutic Products Act (TPA) on 01 January 2019, Switzerland has achieved the greatest possible harmonisation with the system prevailing in the European Union (EU). The EU Variations Guideline has also been fully incorporated in the Therapeutic Products Licensing Requirements Ordinance (TPLRO, Annex 7 List of variations). Swissmedic therefore follows the EMA procedure concerning the implementation of this guideline and would point out that variation applications have to be submitted using the form Variations and extensions, B. Changes in quality and that PLCM documents are not recognised.

Application of the ICH Guideline Q12 in the context of authorisation
Swissmedic applies this guideline with the above-mentioned restrictions to all applications that were submitted on or after 01.04.2020.