Australia has been added to the "list of third countries" as regards standards of manufacture and supervision of active pharmaceutical ingredients equivalent to those of the EU. Following Switzerland, Australia is the second country to be adopted and listed by the European Commission.
EC: Commission implementing decision
The European Medicines Agency (EMA) has upgraded its EudraGMP database so that it now contains information on good distribution practice (GDP) in addition to good manufacturing practice (GMP). The new database is a key deliverable of the new European Falsified Medicines Directive and will make the supervision of manufacturing and distribution of medicines more robust by allowing all the actors in the supply chain to check information available on their suppliers.
India has recently published the revised draft guidelines for the issue of the “Written Confirmation” for APIs exported to the EU in accordance with Article 46(2)(b) of Directives No. 2001/83/EC.
This month the FDA has published the final version of the Guidance for Industry "Blood Establishment Computer System Validation in the User´s Facility". The FDA issued this guidance to assist blood establishments in developing a blood establishment computer system validation program, consistent with recognized principles of software validation, quality assurance, and current good software engineering practices.
On 16 April 2013 the European Commission published Version 4.1 of the Q&A document regarding the importation of APIs to the EU. This version contains two new questions (2A and 10A) and their corresponding answers. Question 11B on atypical active substances –which was only added last week - has been removed as additional discussions with Member States are needed.
The European Medicines Agency and the European Commission have renewed their confidentiality arrangement with Health Canada, the Canadian regulatory authority for medicines, for a further five-year period.
The regulatory authorities will continue their successful cooperation and further extend the exchange of information.
As previously announced by the SFDA, the newly revised "Good Supply Practice for Pharmaceutical Products (GSP)" was recently adopted by the Ministry of Health. It will enter into force on June 1, 2013.
The new GDP Guideline "Guideline on Good Distribution Practice of Medicinal Products for Human Use (2013/C68/01)" has been published on March 8, 2013 in the Official Journal of the European Union. It lays down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain and is of utmost importance for the international pharmaceutical logistic business.
As expected for some time, PDA has now published its "Technical Report No. 60: Process Validation – A Lifecycle Approach". According to PDA, the report presents timely and real world guidance for the application of a lifecycle approach to process validation.
The FDA has recently published a Guidance Agenda which includes all guidances CDER is planning to publish during the calendar year 2013.
The European Medicines Agency (EMA) and the European Commission’s Directorate General for Health and Consumers have renewed their confidentiality arrangement with the Japanese medicines regulatory authorities for a further 5-year period.
The European Commission has submitted the following three drafts for public consultation:
- Guidelines on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
- Guidelines on the principles of good distribution practices for active substances for medicinal products for human use
The European Commission submitted a draft of Version2.0 „Template for the written confirmation for active substances exported to the European Union for medicinal products for human use, in accordance with Article 46b(2)(b) of Directive 2001/83/EC“ to the Pharmaceutical Committee.
Along with the template, a draft of Version 3.0 of the corresponding Q&A document was submitted to the Committee, as well.