The use of Real-world Data (RWD) to produce appropriate Real-world Evidence (RWE) as a basis or supplement for drug efficacy or safety data is in the ascendant.
The Food and Drug
The use of Real-world Data (RWD) to produce appropriate Real-world Evidence (RWE) as a basis or supplement for drug efficacy or safety data is in the ascendant.
The Food and Drug
On 2 July 2020, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia has agreed to the implementation evaluation of bioequivalence (BE) study screening requirements as per instruction letter : NPRA.600-1
MFDS Press Release on 16 July 2020 :
To improve the safety management system of post-approval marketed drugs, the current Post-Marketing Safety System based on the ‘Re-Examination System’ (every 4 –
In order to strengthen the management of the life cycle of drugs and promote the international integration of drug regulatory technical standards, the National Medical Products Administration (NMPA) has announced
The Taiwan FDA issues on 16 July 2020 the guidance on in-vitro companion diagnostic devices (CDx), which are aimed to provide a reference on device efficacy and safety for manufacturers
In order to support the implementation of the new Regulations of Drug Registrations, The National Medical Products Administration(NMPA) of China has published interim regulatory decisions pertaining to drug conditional and
On 01 July 2020, the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia released a guidance document for good manufacturing practice(GMP) inspections for non pharmaceutical category (health supplements, traditional medicines and
Center for Drug Evaluation (CDE) of China published a guideline document pertaining to “Clinical Trial Safety Information Evaluation and Management Standards (Pilot)” (No. 5 in 2020). The guidance document which
On 01 July 2020, China’s NMPA’s Center for Drug Evaluation(CDE) has issued administrative rules titled “Management Guidance/Standard for Development Safety Update Report” (No. 7 of 2020).
The rules were established to