We often encounter in customers’ concerns regarding conducting GLP studies in Israel. These concerns are based on the notion that Israeli-GLP regulation does not meet the regulatory requirements in the U.S. (FDA) and Europe (CE) or, as we have often heard, “this is not a real GLP …”.
The purpose of this post is to refute this concern once and for all and to provide a short explanation about the GLP process with respect to the CE and the FDA.
GLP accredited facilities in Israel are facilities that have been audited and accredited by the Israeli Laboratory Accreditation Authority (ISRAC), which is the body authorized by the CE to examine and authorize laboratories in Israel for the OECD-GLP accreditation. A facility accredited by ISRAC is authorized for activity in a specific area for which it requested the accreditation. The European regulatory authorities require that GLP testing be carried out only in a pre-approved facility for OECD-GLP and only in a field appropriate to the specific study. Laboratories accredited in Israel by ISRAC comply with the CE requirements for the OECD-GLP, or in other words, they do have “REAL-GLP”. For your convenience, a detailed list of all accredited laboratories can be easily found in ISRAC’s website.
In contrast, the FDA does not require preliminary certification of GLP facilities. FDA standards allow for self-declaration of conformity with GLP standards, as outlined in the FDA’s guide (21CFR58). While the FDA process appears more flexible than the CE requirements, in practice the FDA requirements may present a formidable challenge, as the party performing the study must prove to the FDA that the GLP requirements were in fact complied with, including the compliance of the facility in which the study was conducted with GLP standards. It should be noted that in such cases the study file will likely be carefully examined by the FDA to assess compliance with all of the requirements under 21CFR58. Furthermore, using an OECD-GLP approved facility for your study (even if you are applying to the FDA) will likely streamline the FDA approval process as the FDA is well familiar with the high standards utilized in OECD-GLP facilities.
Whether you choose to apply your study file to the FDA or the CE, you should very carefully choose the facility in which the study will be conducted. Make sure that the facility has a well-established quality system and that the facilities conform to the GLP requirements (we can help you with that).
It should be noted that based on my close acquaintance with most of the GLP accredited facilities in Israel, the level of work and compliance with GLP standard requirements is very high and on par with GLP facilities worldwide.