On 11 December 2008, the European Commission published a press release as well as three legislative proposals intended to improve the supply of safe, innovative and accessible medicinal products in Europe. Get more details here.
In October the Center for Biologics Evaluation and Research (CBER) published its annual report for fiscal year 2007 with overviews on the activities of the different CBER competency departments. Get more details here.
The various supervisory authorities have created and published documents for their inspectors, which also give valuable advice to the GCP auditors of the sponsor. On the other hand, they help those who are subject to audits or inspections to prepare for the examination. Here you can find an overview.
On 26 November 2008, the EMEA published a Concept Paper on the Revision of the Guideline on Parametric Release. The revision is carried out in order to take account of the approaches from the ICH Guidelines Q8, Q9 and Q10. Read on here.
As every year, the ECA Advisory Board discussed the organisation’s status and future activities during its annual meeting. This year the meeting was held in Assmannshausen near Frankfurt and concentrated to a large part on the results of the first member survey conducted in the first half of the year. Find out more here.
On this website, the FDA shows the data of the Annual Fatalities Report after Blood Collection and Transfusion, with detailed data concerning the causes like Transfusion Related Acute Lung Injury (TRALI), Hemolytic Transfusion Reactions (HTR) and Microbial Infection. Read more.
With the goal of pushing ahead with the QbD initiative, the US-American health authority FDA made a contract with the National Institute for Pharmaceutical Technology (NIPTE) for 1.19 million US$. Read more here.
The industry has been waiting for the American Food & Drug Administration (FDA) to publish its revision of the Process Validation Guideline. Now the Agency has made its current thinking regarding process validation public. A summary of the new draft can be found here.
Implementation of the Paediatric Regulation: Commission guideline on the format and content of applications for agreement or modification of a paediatric investigation plan and requests for waivers or deferrals and concerning the operation of the compliance check and on criteria for assessing significant studies. Read more.
Within the <Note for Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions> the Q4B Expert Working Group of the EMEA published the drafts of the new Annex 4A, 4B and 4C in June. Read on here.
The FDA published 4 new questions and answers in the section "Production and Process Control". Two answers inform about how to contact the PAT Team. The other two questions deal with the acceptance of ISO 14644 in the field of aseptic processing and the implementation of PAT. You will find more here.
The revision had become necessary in order to adapt the general GMP regulations for active pharmaceutical ingredients (Part II) specifically to the manufacture of herbal medicinal products. Find the details here.
Two new questions and answers have been added to the list of frequently asked GMP related questions. Another Question and Answer has been prepared on active substances whose primary industrial use is not as a pharmaceutical active substance (and the producers of these substances may not be aiming to meet the specific GMP requirements of their pharmaceutical customers). Read more.
The former system with the 3 different kinds of feedback possibilities from the FDA to a submitted application for a marketing authorisation (NDA/ANDA) was not always consistent. The system has now been updated: Read here more.
The competent committee of the European Parliament (Environment, Public Health and Food Safety) adopted the proposed draft regarding variations to the terms of marketing authorisations for medicinal products with the pertaining amendments on 9 September. Two of the changes are quite interesting. Find out more.
The revised Work Plan For GCP Inspectors Working Group for 2008 and a Question and Answer on records of study subject data relating to clinical trials have been published on the EMEA Inspections Section. Read more here.