When the pharmaceutical dealers need to collect, process, or utilize personal data in order to conduct drug safety surveillance, they shall follow the requirements of the Personal Data Protection Act and …

During drug safety monitoring periods (5 years for drugs and 3 years for medical devices), pharmaceutical license-holders shall actively collect worldwide safety information and submit PSUR …

Dec 12, 2025 · Guidelines are intended to provide a basis for practical harmonisation of the manner in which the EU Member States and the EMA interpret and apply the detailed requirements for the …

Dec 22, 2017 · The application criteria, review procedure, approval criteria, and other matters to be complied with shall be established in the Regulations for Registration of Medicinal Product by the …

Effective detection, assessment, understanding and preventing of the adverse effects will enhance patient care and patient safety and to support public health programmes by providing reliable, …

Amendments of the “Guidance for Pre-clinical Testing of Endosseous Implant and Abutment” and the “Guidance for Pre-clinical Testing of Electrosurgical Devices for General Surgery”

Aug 12, 2018 · The TFDA drafts and implements regulations, grants product registration and clinical trial approvals, monitors manufacturing and importation, and conducts safety surveillance activities on …

Regulation (EC) No 726/2004 — procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency

Radiopharmaceutical drugs: drugs meeting the definition given in Article 6, containing radioactive substances for human uses. After being administrated to humans, the drug can diagnose, monitor, …

Dec 1, 2021 · It is an essential component of patient care and rational use of medicines. It is also variously referred to as adverse drug reaction monitoring, drug safety surveillance, side effect …