• RoundupsRoundups

    Asia Regulatory Roundup: Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies   Hong Kong has proposed legislation to create a regulatory framework for advanced therapy products (ATPs), such as interventions based on cells, genes and tissues. The plan is to amend existing laws to create licensing, labeling and record-keeping requirements for ATPs.   Work to update the law ...
  • Regulatory NewsRegulatory News

    Hong Kong Regulators Launch Voluntary Distributor Registration System

    Content provided by Emergo , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Hong Kong’s Medical Device Control Office (MDCO), the region’s medical device market regulator, has set up a  voluntary listing and registration  option for device distributors. Distributors who apply for listing and registration will be searchable under the Medical Device Administrative Control System, the MDCO’s online portal that also ...
  • Hong Kong Petitions to Join PIC/S, Joining Long List of Prospective Members

    • 11 September 2013
    Hong Kong's Pharmacy and Poison Board has petitioned to join the Pharmaceutical Inspection Co-operation Scheme, an international forum for the exchange of regulatory information about pharmaceutical products, joining a bevy of other regulators who have asked to join in recent months. Background The organization is made up of two distinct parts which are different with regard to their authority. The first part, the Pharmaceutical Inspection Convention, is a legally bindi...
  • Report Finds that Pharmaceutical Counterfeiting Busts Fell in 2012

    An annual report just issued by the US Customs and Border Patrol (CBP) shows that counterfeit and pirated goods experienced "explosive growth" in 2012, causing problems for healthcare product regulators who continue to struggle with ways to prevent counterfeit products from entering the supply chain. The Scale of the Problem: Big, but less so for Pharmaceuticals Purveyors of counterfeiters often use a tried-and-true tactic to get counterfeit products into the country:...