Quality of medicines questions and answers (中英文).docVIP

Quality of medicines questions and answers These questions and answers address a number of questions that have been brought to the attention of the?Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have been developed and are maintained by the QWP. They provide the EEAs harmonised position on issues that can be subject to different interpretation or require clarification, typically arising from discussions or correspondence during assessment procedures. If a question is not addressed, marketing-authorisation holders are encouraged to contact the European Medicines Agency for further information at qwp@ema.europa.eu. These questions have been produced to provide clarification or additional information, and should be read in conjunction with the European Pharmacopoeia, quality guidelines and other guidance documents. Key: H: applicable to medicinal products for human use V: applicable to veterinary medicinal products Quality of medicines questions and answers: Part 1： Active Substance - Active-substance-master-file procedure Can a mixture of an active substance with an excipient be submitted through an active-substance-master-file (ASMF) procedure? H+V August 2007. No. A mixture of an active substance with an excipient cannot be submitted through an ASMF procedure. The blending of an active substance and an excipient is considered as the first step in the manufacture of the medicinal product, and therefore does not fall under the definition of an active substance. The only exceptions can be made where the active substance cannot exist on its own, for example, due to insufficient stability without a stabilising agent, or in the case of herbal dry extracts if it is not possible to produce a solid extract without excipients. Acti