The ACAA between the EU and Israel entered into force on 19 January 2013. It is a framework agreement that recognizes Israeli industrial standards as equivalent to European standards and is similar to a Mutual Recognition Agreement (MRAs). Read more.
The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has published a Contingency Plan for exceptional waivers intended to apply where it is necessary to ensure the availability of medicinal products. Read more.
Half-year Report 2013: FDA Medical Devices Warning Letter Statistics - 2 New Deficiency Group in the Top 5
On behalf of the Eurpean Compliance Academy the team of Concept Heidelberg regularly analyses the Warning Letters issued by the FDA. The following information presents the current evolution of the Top 5 hit list - with regard to medical devices - for the first half of fiscal year 2013 (from 1st October 2012 to 31 March 2013). The number of Warning Letters (107) issued by the Center for Devices and Radiological Health (CDRH) and the respective "District Offices" in the first half of fiscal year 2013 is considerably higher. Read more here.
The European Compliance Academy's (ECA) GMP Guideline Manager CD is a very useful tool, providing all relevant guidelines on a single CD. It is distributed to all members of the ECA. This year the CD was issued in its 15th edition. Read more.
Written Confirmations: Time is running out - new EU Progress Report
The EU Commission has published a progress report giving an overview on 20 major countries and their status of preparation for adhering to the new rules. It seems there are still quite a few challenges. Read more.
FDA publishes GMP Requirements for "Combination Products"
As of 22 July 2013, cGMP requirements on combination products will apply in the USA as 21 CFR Part 4. But what are combination products? These are composed of medical products, medicinal products, and ... Read more here.
Sample Documentation on EU Site Master File published
The introduction of the EU Site Master File (Part III of the EU GMP Guide) has significantly changed the requirements on the creation of a company description. The very precise instructions have all disappeared. New requirements have been added. A sample documentation shows how to take into account the new requirements in a SMF. Read more here.
Written Confirmations - How is the EU pharmaceutical Industry dealing with that?
To find out how pharmaceutical companies in the EU are seeing the challenges with the Written Confirmations, the European QP Association conducted a brief survey amongst its members beginning of this year. Almost 300 QPs gave answers to the questions. Read more.