NMPA Formulates Confidentiality Measures

NMPA has Formulated Confidentiality Measures in Regards to Review and Approval of Drugs and Medical Devices.

In order to protect the rights and interests of the manufacturer of pharmaceuticals and medical devices, NMPA (China Food and Drug Administration) issued a code of confidentiality for all employees involved in the registration process.

According to the code, all employees involved in a registration process must sign a confidentiality agreement, whose compliance is strictly monitored. Should an employee be in violation of the agreement, he will be punished. Depending on the severity of the failure, the consequence is a disciplinary punishment which can range from a written warning or dismissal up to legal action against the employee.

If the applicant of the registration can prove that the information disclosed by relevant staff or expert leads to losses, he has the right to file a lawsuit.

If the NMPA pays a compensation according to the judgment of people’s court, they will reclaim part or all of the compensation costs from the violating employee or expert.

For further information please contact:

Cisema GmbH
Tel.: +49 89 4161 7389 00
Fax: +49 89 7484 9956
info@cisema.de
www.cisema.com