The European Union is now recognizing GMP inspections in both Israel and New Zealand, which should lead to less delay in bringing drugs to market and fewer inspections in all three areas.
The EU’s agreement on conformity assessment and acceptance of industrial products (ACAA) with Israel recognises Israel’s industrial standards as equivalent to European standards for drugs, APIs and excipients.
“Products imported into the EU from Israel will no longer need to go through additional ‘quality release’ checks as these have already taken place at the point of manufacture in Israel,” Alexander Brown, a spokesman for Israeli drugmaker Teva, told in-Pharmatechnologist.com. “This will help to remove unnecessary delays in importing medicines into the EU from Israel.”
Israel implemented the relevant EU legislation and aligned its GMP standards, inspection procedures and forms to those used in the EU, according to the ACAA. GMP inspections, import authorizations and the certification of the conformity of each drug batch will be allowed without any rechecking after importation because of the mutual agreement.
Israel will also now participate in EudraGMP, GMP/Good Distribution Practice Inspectors Working Group meetings, and the European Directorate for the Quality of Medicines and Healthcare (EDQM) mutual joint audit programme.
Specifically, the EDQM is evaluating whether Israel can be granted associated status for the Official Medicines Control Laboratories network (OMCLN), Caroline Larsen Le Tarnec, head of public relations and the documentation division of EDQM, told in-Pharmatechnologist.com.
The EDQM first evaluated Israel’s independent control lab in May and is planning another visit soon to see if they comply with requirements necessary for the status. This will allow Israel and the EU to “save a lot of money by sharing work to control the quality of medicines on the market.”
Israel also has been “granted the observer status to the European Pharmacopeia, so we have a long history of exchanging scientific knowledge with Israel,” Le Tarnec said.
The agreement with Israel regarding pharmaceuticals was added to the European Parliament vote in November, which had been stalled for more than two years because of political wrangling.
Meanwhile, the agreement between the EU and New Zealand will allow the acceptance of GMP and quality assurance inspections, and increase the exchange of information between the regulators on these inspections. Active pharmaceutical ingredients and clinical trial products fall under the agreement.
An alert system notifying either country on any new information on quality defects, batch recalls or counterfeiting will also be established, and both countries will certify that the manufacturers operating in their countries are appropriately authorized, inspected regularly and in compliance with GMP requirements.
However, New Zealand is not an official observer of the European Pharmacopeia and is not working with the EDQM, Le Tarnec said.
A joint committee with representatives from both New Zealand and the EU will meet at least once a year to discuss amending the agreement, exchange information on forthcoming regulatory or legislative updates, and appoint a team of experts to verify the technical competence of conformity assessment bodies in each country.
The agreement with New Zealand comes as the creation of the Australia New Zealand Therapeutic Products Agency (ANZTPA) takes shape. ANZTPA is expected to be complete by 2016 and reduce regulatory costs, as well as improve the standard of therapeutic goods produced in both countries.