Pharma & Biotech
BPOM confirms pharmaceutical authorization, GMP oversight, and regulatory authority remain unchanged under the Indonesia–US trade agreement.
Vietnam’s MoH recently published Circular drops several healthcare advertising regulations and streamlines requirements for many categories.
Malaysia’s NPRA introduces reliance and priority review pathways for additional indications of registered innovator drugs.
China releases guiding principles for benefit-risk assessment using multi-regional clinical trial data to support global drug development.
China releases new subject selection guidance for anti-tumor drug bioequivalence and pharmacokinetic studies.
Hong Kong’s Department of Health introduces Pre-NDA meetings to streamline new drug registrations under the “1+” mechanism.
Malaysia’s NPRA issues Directive No. 7 of 2026 mandating the Malaysian Guideline for GCP 5th Edition for clinical trials.
Malaysia’s NPRA mandates DEG and EG testing for high-risk oral liquid products , with mandatory compliance starting April 1, 2027.
On October 30, 2018, the NMPA issued guidelines for the approval of clinically urgent new drugs covering the procedure, requirements, etc.
On 25.06.2019, the NMPA announced the requirements for overseas new drugs, which are urgently needed. The guidelines serve to speed up the drug approval.
On 01.07.2019, the 2018 Drug Review Annual Report was released. Of the grand sum of 9,796 registration applications reviewed and approved in 2018, 7,988 were subject to technical review and 1,808 to direct administrative approval.
One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...|One of the primary objectives of China's centralized procurement mechanism is ensuring that the medicines and medical consumables...
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