ARTICLE

Hong Kong Shifts to Independent Drug Assessment

Hong Kong is initiating a phased shift towards independent assessments for new drug submissions. This move aims to enhance the efficiency and transparency of the regulatory process, aligning with international best practices.

REGULATORY · HSA

HSA Accepts eCTD Submissions

The Health Sciences Authority (HSA) of Singapore has been accepting electronic Common Technical Document (eCTD) format submissions since April 1, 2025, streamlining the application process for pharmaceutical companies.

REGULATORY · PMDA

Guidance on Manufacturing Changes

The Pharmaceuticals and Medical Devices Agency (PMDA) has issued guidance on pre-specifying manufacturing change categories under ICH Q12, enhancing clarity in the application process for marketing approvals.

REGULATORY · NMPA

NMPA's IMDRF Participation

The National Medical Products Administration (NMPA) continues its involvement in the International Medical Device Regulators Forum (IMDRF), promoting harmonization in medical device regulation across member countries.

NEWS

APACMed's Regulatory Reliance Pathways

APACMed is actively tracking regulatory reliance pathways across the region, providing valuable insights for companies looking to navigate the complex regulatory landscape effectively.

NEWS

TGA's Abridged Conformity Assessments

The Therapeutic Goods Administration (TGA) has released guidance leveraging assessments from overseas regulators, such as the PMDA and FDA, to facilitate abridged conformity assessments for medical devices.

NEWS

Growth of Regulatory Reliance in APAC

Regulatory reliance is gaining momentum in the APAC region, with various authorities exploring partnerships to streamline approval processes and enhance market access for pharmaceutical products.