The British Pharmacopoeia on Monday released its response to its consultation on dissolution testing and announced its plans to update its approach within its product monographs.   The British Pharmacopoeia first launched the consultation in January 2017 to gather input from stakeholders on ways the pharmacopoeia could improve its approach to dissolution testing in its finished product monographs.   Dissolution testing is performed for solid oral drugs to determi...

The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical ingredients (APIs) of interest to both Europe and Japan. The agreement follows the exchange of letters on 13 September 2016 in which Japan’s Pharmaceutical Safety and Environmental Health Bureau of ...

This article provides a high-level introduction to the Chinese regulatory framework, including requirements for marketing approval of imported drugs. An increasing number of pharmaceutical companies based outside China are interested in marketing their products in China as evidenced by the increasing number of clinical trial and marketing applications submitted by foreign companies. Obtaining marketing authorization approval equal to an Import Drug License (IDL) approv...

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Releases Medical Device Adverse Event Reporting Form for Consultation The Indian Pharmacopoeia Commission (IPC) has released a medical device adverse event reporting form for consultation. IPC has drafted the template as part of the drive in India to establish a materiovigilance program to monitor the safety of medical devices. Once the form is finalized, filers o...

The US Food and Drug Administration (FDA) has adopted and released a new guidance document intended to clarify the International Conference on Harmonisation's (ICH) Q4B guideline on the use of pharmacopoeial texts. Background ICH is a regional harmonization group composed of the US, EU and Japan, as well as other countries which serve in a voluntary capacity. The aim of the group is to allow the regulatory processes of each to better align with those of the others,...

The International Conference on Harmonisation (ICH) has announced the release of a new quality document pertaining to the bulk density and tapped density of powders, saying two existing pharmacopoeial texts may be interchangeable within the ICH regions. The ICH is composed of three regions: the US, the EU and Japan. Two of the region's pharmacopoeias-the EU Pharmacopoeia and the US Pharmacopoeia-both have guidance documents available pertaining to the bulk density and ta...

The US Pharmacopoeia (USP) and the British Pharmacopoeia (BP) have announced the harmonization of two drug product quality standards for two eye drop medications-a first for the two groups and an effort that could lead to more cooperation between the two groups in the future. The newly-harmonized standards cover dorzolamide hydrochloride ophthalmic solution and dorzolamide hydrochloride-timolol maleate ophthalmic solution, and are included in the Pharmacopeial Forum 38(...

The Chinese State Food and Drug Administration (SFDA) issued a notice on 25 April to Chinese Provinces and Municipalities regarding the deadlines for implementing the revised Good Manufacturing Practices (GMPs) for ophthalmic solutions. The circular pointed out that the implementation of revised GMPs for sterile pharmaceuticals and sterile bulk drugs is effective as of 31 December 2013. These sterile bulk drugs include ophthalmic preparations, such as those for intra...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA)  appointed John Wilkinson, OBE , as the Director of Medical Devices at the agency on 8 February 2012. Wilkinson comes to MHRA from EUCOMED, where he served as the chief executive. Before that, Wilkinson served as the Director General of the Association of British Healthcare Industries (ABHI) for four years. MHRA also made five new appointments to the British Pharmacopoeia Commission (BPC) on 8 Fe...