Enzolytics Inc (ENZC)

[Shell Man]

FDA/EUROPEAN UNION Mutual Recognition Agreement (MRA)
https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra

ENZC AND IMMUNOTECH ARE CONDUCTING PHASE IV TESTING IN BULGARIA

Countries Recognized April 29, 2019
Country Regulatory authority for medicinal products for human use*
Bulgaria Bulgarian Drug Agency


"The Mutual Recognition Agreement (MRA) between FDA and European Union allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders."


"Enzolytics currently holds a 49% Interest in Immunotech Laboratories BG-Europe. Immunotech BG-Europe has a license for the development and commercialization of Enzolytics Patented ITV-1 Technology. Immunotech BG-Europe , under the branded ImmunH , utilizing the technology has successfully completed Phase III clinical trials at the Specialized Hospital for Active Treatment of Infectious and Parasite Disease in Sofia, Bulgaria, specific for the treatment of HIV/AIDS."

ImmunoTech Laboratories BG-Europe has filed for a mass use permit, Phase IV, in Bulgaria. Enzolytics is seeking a Contract Manufacturing Organization (CMO) in the United States to produce the Immunotherapy Treatment to be used as the validation batch in coordination with the Bulgarian regulatory authority and Immunotech BG-Europe.

Additionally, ImmunoTech BG-Europe has informed Enzolytics that they will be seeking to register the ImmunH product as a ImmuneModulator, allowing use as an adjunct in additional applications to regulate or normalize the Immune System."






The Mutual Recognition Agreement (MRA) between FDA and European Union allows drug inspectors to rely upon information from drug inspections conducted within each other’s borders. Under the Food and Drug Administration Safety and Innovation Act, enacted in 2012, FDA has the authority to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities if the FDA determined those authorities are capable of conducting inspections that met U.S. requirements. FDA and the EU have collaborated since May 2014 to evaluate the way they each inspect drug manufacturers and assess the risk and benefits of mutual recognition of drug inspections.

"MRA: Yields greater efficiencies for U.S. and E.U. regulatory systems by avoiding duplication of inspections
Enables reallocation of resources towards inspection of drug manufacturing facilities with potentially higher public health risks across the globe
FDA will continue to perform some inspections in EU countries with capable inspectorates, such as product manufacturing assessment inspections to support marketing approval decisions. However, FDA expects to perform fewer routine surveillance inspections in EU countries with a capable inspectorate.

FDA is collaborating with the following inspectorates it has assessed as capable and is reviewing their recent inspection reports and related information in determining each manufacturer’s suitability for the U.S. market in lieu of an FDA site inspection. FDA expects to complete its capability assessment of all EU inspectorates by July 2019."