Snapshot

The Health Drug Registration for Homologation pathway has been developed by the Agencia Nacional de Regulación, Control y Vigilancia Sanitaria of Ecuador.

This pathway can be used where all therapeutic products.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Canada EU-EMA Japan South Korea United States WHO

The user must enter into the electronically automated system for granting the Health Registration Certificate, and once they have obtained their password, fill in the relevant application, and will enter the required information in the application form for registration of health registration medicines for homologation. The user must scan and enter into the system all the documents required. The National Agency for Regulation, Control and Health Surveillance -ARCSA, or the agency performing its duties, in the term of one day, shall verify whether the documentation is complete and if the information entered in the application is correct. Once the documentation is complete and correct, payment of health registration is allowed. The system will notify the user the amount payable and the deadline for such payment, and the forms provided. Once the user makes the payment and is verified by the National Agency for Regulation, Control and Health Surveillance, an electronic invoice is created in the system and automatically sent to the user for printing. After this process, the documents will be distributed to the departments responsible for the evaluation thereof, and within five (5) days the Health Registration Certificate shall be issued. The Health Registration Certificate will be published in the system and available for the user to have access to it.