European Pharmacopoeia Commission propose new policy for dissolution and disintegration testing in Ph. Eur. monographs

European Pharmacopoeia Commission decided to include a dissolution or disintegration test in each medicinal product monograph on an immediate-release solid dosage form.

The details of the scope of such a test and the conditions for its use in a marketing authorisation application will be included in the General Notices (Chapter 1 of the Ph. Eur.). An excerpt is shown below:

“In line with the relevant guidelines applied nationally or regionally (such as the ICH Q6A guideline) and with the relevant Ph. Eur. dosage form monograph, a suitable product-specific dissolution test has to be proposed by the applicant for routine quality control to confirm batch-to-batch consistency. This test must be described in the MAA for submission to the competent authority, unless there is data justifying the replacement of the dissolution test by a disintegration test (see below). The demonstration of the suitability of the dissolution test has to be made by the applicant to the satisfaction of the competent authority.

Where appropriate, a dissolution test is described in an individual monograph on a medicinal product. In such cases, the applicant may either select the monograph dissolution test or develop an in-house dissolution test as the product-specific dissolution test. In any case, the applicant has to demonstrate the suitability of the selected test to the satisfaction of the competent authority.

If an in-house dissolution test is proposed, justification for not selecting the monograph dissolution test and demonstration of compliance with the monograph dissolution test is normally not requested in the MAA.

However, when tested, the medicinal product has to comply with the monograph dissolution test, unless otherwise justified by the applicant.

Where a given medicinal product does not comply with the monograph dissolution test and this product is approvable by a competent authority, then the competent authority shall bring this to the attention of the Ph. Eur. Commission so it can review the monograph and revise it where appropriate.”