شروط الحماية القانونية لبيانات الاختبارات و نتائج التجارب الدوائية في القانون الأردني : دراسة مقارنة

Abstract EN

This study investigates the conditions which Regulatory Pharmaceutical Data (RD) must meet to be protected against unfair commercial use and disclosure.

Such data is provided to the Jordanian Food and Drug Bureau (JFDA) by sponsors of new drug applications to prove the intoxicity, potency, and quality of their new drugs.

This study establishes that the mere submission of RD to the JFDA does not justify legal protection.

To qualify for protection RD must satisfy the following conditions: it must derive from lab tests and clinical studies; it must relate to a product containing a new chemical entity that has never been used or disclosed before in any form; it must be confidential and kept secret, unknown to, or easily accessible by people dealing with such data it it must be required and necessarily lead to approval of the associated drug; and must require a considerable effort to generate.