| 2024-08-22 |
On 22 August 2024, the Drug Office held a meeting to brief licensed pharmaceutical manufacturers and potential applicants on GMP issues, regulatory updates, and the implementation details of the PIC/S GMP Guide (PE 009-17). The session also included presentations from the Hong Kong Pharmaceutical Manufacturers Association (“HKPMA”) and the School of Pharmacy of the Chinese University of Hong Kong (“CUHKSOP”), who provided updates on the development of the toxicological evaluation platform (“TEP”). Representatives from all licensed pharmaceutical manufacturers (100%), and four potential applicants or relevant traders attended the meeting.
The primary focus of the meeting was the adoption of the PIC/S GMP Guide (PE 009-17), which was scheduled to take effect on 1 July 2025. The Drug Office outlined the planned transition, emphasizing the results of a recent survey assessing the progress of GMP upgrades among local manufacturers, and addressed specific industry concerns. The mechanism for adopting future GMP Guide was also discussed, followed by a Q & A session to address any remaining questions.
Additionally, the HKPMA and CUHKSOP highlighted the latest development of the AI-aided TEP, including the platform’s calculations, technical routes, validation, and the expected development timeline.
The attendees were also briefed on statistics on GMP inspections and common GMP deficiencies identified in 2023, along with various regulatory updates. These updates included recent revision of PIC/S and ICH guidelines, the regulation of medical gases, the upregulation of sales control of certain pharmaceutical products, the development of the Computerized Transaction Record (“CTR”) system, and amendments of the Dangerous Goods Ordinance. The various drug regulatory initiatives mentioned in The Chief Executive’s 2023 Policy Address were also shared with the attendees. |
| 2021-12-09 |
On 8 and 9 December 2021, the Drug Office held two identical online meetings to brief licensed secondary packaging manufacturers, their registered authorized persons (APs) and potential applicants on GMP inspection and regulatory updates. 91% of licensed secondary packaging manufacturers, 78% of relevant registered APs as well as representative of one potential applicant of secondary packaging manufacturers and one potential applicant of AP attended the meetings. During the meetings, the attendees were briefed on statistics on GMP inspections and common GMP deficiencies identified in 2020, and updates on PIC/S GMP Guide & annexes. In addition, there was an introduction of the regulatory updates regarding the commencement of the Pharmacy and Poisons (Amendment) Ordinance 2020 on 1 August 2021, the associated revision to the Code of Practice for licensed manufacturers and registered APs, and the establishment or revision of guidance documents that were published recently in the websites of the Pharmacy & Poisons Board and the Drug Office. Besides, a briefing on the trade consultation of the Revised “Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products” which will finish on 22 April 2022 was provided to the attendees. Furthermore, the attendees were reminded of requirements of the Continuous Professional Development (CPD) Programme. The meetings finished up with respective Q & A sessions. |
| 2021-08-09 |
On 9 August 2021, the Drug Office held an online meeting to brief licensed pharmaceutical manufacturers, registered authorized persons (APs) of pharmaceutical manufacturers and potential applicants on GMP inspection and regulatory updates including the commencement of the Pharmacy and Poisons (Amendment) Ordinance 2020 (Amendment Ordinance) on 1 August 2021. 91% of licensed pharmaceutical manufacturers, 78% of registered APs as well as representatives of 9 potential applicants of pharmaceutical manufacturers and 3 potential applicants of AP attended the meeting. During the meeting, the attendees were briefed on statistics on GMP inspections and common GMP deficiencies identified in 2020, and updates on PIC/S GMP Guide & annexes. In addition, there was an introduction to the regulatory updates regarding the commencement of the Amendment Ordinance, the associated revision to the Code of Practice for licensed manufacturers and registered APs, and the establishment or revision of guidance documents that were published recently in the websites of the Pharmacy & Poisons Board and the Drug Office. The meeting finished up with a Q & A session. |
| 2021-01-12 |
On 12 January 2021, the Drug Office held an online meeting to brief licensed pharmaceutical manufacturers, registered authorized persons (APs) of pharmaceutical manufacturers and potential applicants on GMP inspection, Continuous Professional Development (CPD) Programme and regulatory updates including those for advanced therapy products (ATPs). All (100%) licensed pharmaceutical manufacturers, about 74% of registered APs and representatives of 11 potential applicants of pharmaceutical manufacturers as well as 5 potential applicants of AP attended the meeting. During the meeting, the attendees were briefed on statistics on GMP inspections, common GMP deficiencies identified in 2019, the implementation of CPD, outcomes of a recent survey related to the updates of GMP Guide and the enhanced regulatory control for skin antiseptic products. In addition, there was an introduction to regulatory regime of ATPs, associated law amendment and the series of guidance documents (drafts and final) designated for the ATP industry that were published recently in the Drug Office’s website. The meeting finished up with a Q & A session.
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| 2019-06-17 |
On 17 June 2019, the Drug Office held a meeting with licensed pharmaceutical manufacturers on GMP and manufacturer's licensing issues. All (100%) licensed manufacturers, representatives of 9 potential applicants of pharmaceutical manufacturers of advanced therapy products (ATPs) and representatives of 1 local GMP/ATP training provider attended the meeting. During the meeting, the attendees were briefed on statistics on GMP inspections, common GMP deficiencies identified in 2018, updates on PIC/S GMP Guide & annexes, and guidance for ATPs. In addition, there was an introduction to the new application forms and guidance documents for industry published recently or to be published in the Drug Office’s website. The meeting finished up with a Q & A session.
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| 2018-10-03 & 2018-10-16 |
On 3 & 16 October 2018, the Drug Office held two identical meetings to brief the licensed secondary packaging manufacturers on GMP issues in respect to GMP inspection and Continuous Professional Development (CPD) Programme. Representatives from 90% of licensed secondary packaging manufacturers and representatives of a local GMP training provider attended the meeting. During the meeting, issues regarding the common deficiencies identified during GMP inspection in 2017 and relevant clauses in the Hong Kong GMP Guide for the Secondary Packaging of Pharmaceutical Products to those deficiencies were discussed. In addition, there was also a brief on the implementation plan on the CPD Programme for authorized persons and persons-in-charge of secondary packaging for the secondary packaging manufacturers. The meeting finished up with a Q & A session.
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| 2018-10-03 & 2018-10-16 |
On 3 & 16 October 2018, the Drug Office held two identical meetings to brief the registered authorized persons (APs) of the pharmaceutical manufacturers, applicants and potential applicants for a licence to manufacture Advanced Therapy Products (ATPs) on the licensing requirements for manufacturing ATPs. About 42% of registered APs, representatives from 74% licensed pharmaceutical manufacturers, representatives of 20 applicants and potential applicants of pharmaceutical manufacturers of ATPs and representatives of 2 local GMP training providers attended the meeting. The proposed definitions and regulatory framework of ATPs, licensing requirements for ATP manufacturing, the PIC/S GMP Guide and relevant Annexes, Code of Practice for licensed manufacturers and APs as well as requirements for key personnel were presented to the audience. In addition, there was also a brief on the implementation plan on the Continuous Professional Development Programme for APs of pharmaceutical manufacturers including ATP manufacturers. The meeting finished up with a Q & A session.
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| 2018-04-24 |
On 24 April 2018, the Drug Office held a meeting to brief licensed pharmaceutical manufacturers on issues related to the Hong Kong Strategy and Action Plan on Antimicrobial Resistance, the adverse drug reaction reporting system, the implementation of Continuing Professional Development requirements, and GMP inspection & deficiencies. During the meeting, anti-corruption messages were also disseminated to the audience by a guest speaker from the Hong Kong Independent Commission against Corruption (ICAC). All (100%) licensed manufacturers and a number of prospective applicants for Licence for Manufacturer attended the meeting. The meeting finished up with a Q & A session.
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| 2017-03-17 & 2017-03-24 |
On 17 & 24 March 2017, the Drug Office held two identical meetings to brief the licensed secondary packaging manufacturers on GMP issues in respect to GMP inspection, Change of particulars on the Licence for Manufacturer and Continuous Professional Development Programme. About 92% of licensed secondary packaging manufacturers and representatives from 4 local GMP training providers attended the meeting. During the meeting, issues regarding the lifecycle of GMP inspection from notification to closing; the common deficiencies identified during GMP inspection in 2016; handling the inspection reports and inspection close out records; preparation for the application and approval for change of particulars and the key inspection areas in 2017 were discussed. In addition, there was also a brief on criteria for recognition of a certified GMP training and the continuous professional development programme for authorized persons and person-in-charge of secondary packaging for the secondary packaging manufacturers. The meeting finished up with a Q & A session.
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| 2017-02-24 |
On 24 February 2017, the Drug Office had a meeting with the licensed pharmaceutical manufacturers on GMP issues related to GMP inspection, change of particulars on the Licence for Manufacturer and Continuous Professional Development Programme. All (100%) licensed manufacturers attended the meeting. During the meeting, the licensees were briefed on the GMP inspection issues, including the lifecycle of GMP inspection from notification to closing; the common deficiencies identified during GMP inspections in 2016; handling the inspection reports and inspection close out records; preparation for the application and approval for change of particulars on the licence for manufacturer and the key inspection areas in 2017. In addition, there was also a brief on details regarding the continuous professional development programme for authorized persons and key personnel in the manufacturers. The meeting finished up with a Q & A session.
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| 2016-05-05 |
On 5 May 2016, the Drug Office held a meeting to brief the licensed pharmaceutical manufacturers (secondary packaging) on GMP issues in respect to the implementation progress, the inspection procedures, the inspection report format, and the GMP deficiencies follow-up. About 76% of licensed manufacturers (secondary packaging) and representatives from 3 potential applicants attended the meeting. The meeting finished up with a Q & A session.
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| 2015-09-14 |
On 14 September 2015, the Drug Office had a meeting with the licensed pharmaceutical manufacturers in Hong Kong in connection with the upgrade of the local GMP standard to PIC/S standards. All (100%) licensed manufacturers attended the meeting. During the meeting, issues on the roadmap to PIC/S standard, separation of production areas for cephalosporins from penicillins, task force meeting on compressed air and temperature mapping, change of particulars on key personnel and premises, submission of process validation protocol and report for change of registered particulars, equipment qualifications, computer system validation, testing of starting materials, GMP upgrade progress of the local manufacturers and the renewal of registration as Authorized Person had been discussed. The meeting finished off with the Q & A session.
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| 2015-08-24 |
On 24 August 2015, the Drug Office had a briefing session with the licensed pharmaceutical manufacturers (secondary packaging) on the Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products, GMP inspection procedures, GMP inspection report format, and follow-up of GMP deficiencies. About 87% of licensed manufacturers (secondary packaging) and representatives from 1 potential applicant attended the meeting. The meeting finished off with the Q & A session.
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| 2015-04-20 |
On 20 April 2015 afternoon, the Drug Office had a briefing session with the licensed pharmaceutical manufacturers on the draft “Code of Practice for Licensed Manufacturers and Registered Authorized Persons”. In addition to the code of practice, issues on the registration of Authorized Persons and new procedures relating to application for change of particulars were discussed. About 80% of licensed manufacturers attended the meeting. The meeting finished off with the Q & A session.
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| 2015-04-20 |
On 20 April 2015 morning, the Drug Office had a briefing session with the licensed pharmaceutical manufacturers (secondary packaging) on the draft “Code of Practice for Licensed Manufacturers and Registered Authorized Persons”. About 76% of licensed manufacturers (secondary packaging) and representatives from 3 potential applicants attended the meeting. The meeting finished off with the Q & A session.
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| 2015-02-27 |
On 27 February 2015, the Drug Office had a meeting with the licensed pharmaceutical manufacturers in Hong Kong in connection with the upgrade of the local GMP standard to PIC/S standards. About 80% licensed manufacturers attended the meeting.
During the meeting, issues on the progress of PIC/S upgrade of the local manufacturers and computerized system validation were discussed. The meeting finished off with the Q & A session.
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| 2014-12-15 |
On 15 December 2014, the Drug Office had a meeting with the licensed pharmaceutical manufacturers in Hong Kong in connection with the upgrade of the local GMP standard to PIC/S standards. About 80% licensed manufacturers attended the meeting. Common deficiencies observed during the GMP inspections were discussed. The meeting finished off with the Q & A session.
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| 2014-12-04 & 2014-12-08 |
On 4 and 8 December 2014, the Drug Office held 2 identical meetings to brief licensed pharmaceutical manufacturers (secondary packaging) on the issues about licensing of secondary packaging operations and qualification and experience requirements of key personnel. Overall, 92% of licensed manufacturers (secondary packaging) and representatives from 18 potential applicants attended the meetings. The meetings finished off with the Q & A session.
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2014-10-17
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On 17 October 2014, the Drug Office briefed licensed pharmaceutical manufacturers on the new licensing condition which requires full compliance with the PIC/S GMP Guide with effect from 1 October 2015. About 78% of licensed pharmaceutical manufacturers attended the meeting. The Guidance for Industry on Computerized System Validation and issues related to the risk-based scheduling of inspection were also discussed. The meeting finished off with the Q & A session.
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2014-10-13
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On 13 October 2014, the Drug Office held a meeting to brief licensed pharmaceutical manufacturers (secondary packaging) on the new licensing condition which requires them to fulfil the PIC/S GMP standard with effect from 1 October 2015. In this connection, changes to the draft Hong Kong Guide to Good Manufacturing Practice for the Secondary Packaging of Pharmaceutical Products were also discussed. Over 90% of licensed manufacturers (secondary packaging) and representatives from 28 potential applicants attended the meeting. The meeting finished off with the Q & A session.
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2014-07-31
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On 31 July 2014, the Drug Office had a meeting with the licensed pharmaceutical manufacturers in Hong Kong in connection with the upgrade of the local GMP standard to PIC/S standards. About 63% licensed manufacturers attended the meeting. During the meeting, issues on the progress of PIC/S upgrade of the local manufacturers, inspection close out records were discussed.
The meeting finished off with an overview on the Guidance Notes for Industry on Starting Material Supplier Management and Q & A session.
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2014-04-15
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On 15 Apr 2014, the Drug Office had a seminar with all the licensed pharmaceutical manufacturers (secondary packaging) in Hong Kong for the introduction of GMP issues related to secondary packaging. Over 75% of licensed pharmaceutical manufacturers (secondary packaging) and 14 potential applicants companies attended the meeting.
During the meeting, GMP issues related to secondary packaging regarding premises, personnel, operation, quality control and others were discussed. The meeting finished off with the Q & A session.
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2014-04-07
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On 7 Apr 2014, the Drug Office held a briefing session on the draft code of practice (COP) for pharmaceutical manufacturers and authorized persons with all the licensed pharmaceutical manufacturers (secondary packaging) in Hong Kong and potential applicants. Over 85% of licensed pharmaceutical manufacturers (secondary packaging) and 17 potential applicants attended the session. In addition, GMP issues related to secondary packaging regarding documentation was discussed. The meeting finished off with the Q & A session.
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2014-03-27
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On 27 Mar 2014, the Drug Office held a meeting to brief the licensed pharmaceutical manufacturers in Hong Kong on “Guidance Notes for Industry” which includes “Quality Risk Management”, “Contract Testing Laboratories” and “Microbiology Laboratories”. Around 60% licensed manufacturers attended the meeting.
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2014-03-11
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On 11 Mar 2014, the Drug Office briefed the licensed pharmaceutical manufacturers in Hong Kong on the draft code of practice (COP) for Hong Kong pharmaceutical manufacturers and authorized persons. Around 60% licensed manufacturers attended the meeting.
In the meeting, issues on purpose of the COP, obligations and requirements for pharmaceutical manufacturers and authorized persons, penalties on non-compliance, duties of authorized persons on release of finished products and requirements for continuing professional development were discussed. Compliance with the COP would be one of the licensing conditions for manufacturer licence and conditions of registration of authorized person.
The meeting finished off with the Q & A session.
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2014-01-08
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On 8 Jan 2014, the Drug Office had a meeting with the licensed pharmaceutical manufacturers in Hong Kong in connection with upgrade of the local GMP standard to PIC/S standards. About 77% licensed manufacturers attended the meeting.
During the meeting, issues on the progress of PIC/S upgrade of the local manufacturers, the commencements of 18 months transition period starting from 1 January 2014 where local manufacturers will be given the option of being inspected to either the Hong Kong GMP Guidelines for pharmaceutical products or the PIC/S GMP, changes related to inspection report format, close-out record etc. were discussed.
The Drug Office had also reminded licensed manufacturers that new licensing conditions which includes the requirements of ADR reporting, document quality defects, recall notification and restriction in the use of contracted laboratories etc. would be imposed upon the renewal of licence for manufacturers in 2014. In addition, from 2014 onwards, licensed manufacturer who had contracted out all of its manufacturing activities would also be prohibited from conducting secondary packaging operations unless approved by the Pharmacy and Poisons (Manufacturers Licensing) Committee.
The meeting finished off with a brief overview on two new Guidance Notes for Industry on Process Validation and Product Quality Review (which would be uploaded to the website of the Drug Office by the end of January 2014) and Q & A session.
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