Newsletter â HK and Asia Regulatory - BSI America

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2. HKAPI updateSabrina Chan (from Hong Kong Association of Pharmaceutical Industry)provided updates on pharmaceutical regulatory issuesConvener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comPotential new requirement of microbial testing in HospitalAuthority1. Proof of compliance to microbiological test requirementsa. Sterile Product: Proof of sterility through evidence shown on productb. Non-sterile Product: Proof of compliance to microbiological test requirementsof BP, USP, or EP2. More routine sample testing:a. Testing method: ID and Assay, microbiological testingb. Frequency: increased and routine with schedule3. Supply of batch release reports4. Additional Information on delivery notea. Registration particulars: eg. registration numbers, expiry date…5. Multi-sourcing6. A valid Check and Chase system – supply chain logisticsProduct Classification servicePlease note Hong Kong Department of Health has stopped classificationservice for pharmaceuticals.* Message from BSIPlease contact BSI if you need Classification service from third parties
3. Macau RegulatoryHKMRS (Hong Kong and Macao Regulatory Service Limited) is a HKconsultancy company providing regulatory services to clients in HK andMacao.Convener ContactJack WongAHWP Hong KongrepresentativeEmail:jack.wong@bsigroup.comIn additional to regulatory services for pharmaceutical products and
Page 1: Newsletter - HK and Asia Regulatory
Page 4 and 5: The intent of standard is to ensure
Page 6 and 7: Hong Kong Regulatory Forum Update1.
Page 10 and 11: Convener ContactJack WongAHWP Hong
Page 12 and 13: 5. Hong Kong Regulatory updateConve
Page 14 and 15: Communicating Effectively: An IPO I
Page 16 and 17: Regulatory TrainingsBSI is the lead
Page 18 and 19: China and Global Medical Device Reg
Page 20 and 21: Others and Special Offers to Forum
Page 22 and 23: Emily ChiangJessie WongErica PoonSu
Page 24: Mr CHIU Chi-Sang (LUCIANO BAPTISTA)
Page 30 and 31: 21-22October2009,DanubiusHotelRegen

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Newsletter â HK and Asia Regulatory - BSI America