Quite recently, the FDA published "The Enforcement Story" Report. The Enforcement Story describes FDA's accomplishments and enforcement-related activities in all product areas over which FDA has jurisdiction. The report contains interesting statistics, like the Enforcement Statistic from CDER (regulating drugs). You will find more here.
The EMEA published two documents that co-ordinate and focus the activities of the supervisory- and registration authorities of all EU member states and of the EDQM in the case of serious GMP deficiencies on the part of manufacturers of active ingredients and investigational medicinal products. Which consequences e.g. the suspension of an API manufacturer's CEP can have for a manufacturer of medicinal products can be read here.
The new guidance will provide information about the requirements for postmarketing studies and clinical trials under section 505(o) of the Act. The guidance also describes the types of postmarketing studies and clinical trials. Read more.
The DMA has launched a project focusing on compliance with the rules by manufacturers of active pharmaceutical ingredients in 2009. In connection with the project, the DMA will spot check whether the rules are followed in connection with the manufacture and handling of API. You will find more here.
The EDQM issued documents for qualifying analytical equipment, and more recently also published documents for the validation of computerised systems. These guidelines are certainly not valid for the pharmaceutical industry. However, compared with own proceedings their contents are quite interesting. To learn where you can find these documents, read here.
Public consultation on draft revision 3 of Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial. Read more.
The European Medicines Agency (EMEA) has released a draft transparency policy for public consultation. It sets out how the Agency intends to provide for greater clarity and openness in all areas of its operations. Read more.
The 2009 Edition of the Canadian GMP Guidelines (GUI-0001) introduces new aspects into the Canadian GMP regulations. When reading some of the new parts one might think that these GMPs are influenced by European GMPs. Read more.
Following the publication of the report on an impact assessment study by an external contractor DG Enterprise and Industry has taken the decision not to continue with the preparation of a Commission Directive on GMP for certain excipients. But this may lead to a wrong interpretation. Here you will find more.
A Guidance for coordination of GCP inspections and co-operation between GCP inspectors has been published in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures. Read more.