Hong kong drug registration guidelines. Guidelines & Forms; .

Hong kong drug registration guidelines the purposes of sale, distribution or other use in Hong Kong. Oct 31, 2023 · Under the current Pharmacy and Poisons Ordinance in Hong Kong, pharmaceutical products must meet strict criteria for safety, efficacy, and quality before selling into the market. According to the training requirement of the Pharmacy and Poisons Board (“the Board”), graduates of local accredited Bachelor of Pharmacy (“BPharm”) Programmes offered by The University of Hong Kong (“HKU”) and The Chinese University of Hong Kong (“CUHK”) are required to undergo Board-approved training in Hong Kong for one year (inclusive of a holiday entitlement of not more Feb 15, 2023 · Drug Registration. (Enquiries: 2319 8458) How to apply? 8. The Drug Office of Department of Health (DH DO) is the executive arm of the Committee. Wholesale Trader/ Importer and Exporter. In this section, we delve into the essential guidelines and the key authorities that govern drug registration in Vietnam. This figure highlights the importance and demand for pharmaceutical products in the region. A key focus is the reform of approval mechanisms for drugs and medical devices, aimed at expediting access to essential treatments and strengthening the Aug 28, 2024 · The Regulations on the Administration of Import of Drugs and Medical Devices from Hong Kong and Macao into the Nine Cities in the Guangdong-Hong Kong-Macao Greater Bay Area of Guangdong Province are designed to streamline and enhance the management of urgently needed imports from Hong Kong or Macao as part of the HK-GBA connect scheme Navigating the drug import regulations in Hong Kong requires careful attention to detail and a thorough understanding of the local regulatory landscape. Hong Kong pharmaceutical products are required to be registered by the Pharmacy and Poisons Board (PPB) before sale. SPECIAL ADMINISTRATIVE REGION. The purpose is to ensure that medicines available for sale are safe, effective and of good quality. (a) Drug Surveillance Programme . This suggests a positive outlook for the pharmaceutical industry in Hong Kong Since November 6, 2019, registration of drugs in Hong Kong has become much more attractive to overseas medical device manufacturers because manufacturers may seek to take advantage of the Greater Bay Area “connect scheme”. How to apply 1. Drug Office, Department of Health . 0; Jan 19, 2016 · 4. If there is extensive clinical experience with the drug and no reason to suspect a different Oct 29, 2024 · Hong Kong’s 2024 Policy Address, presented by Chief Executive John Lee on October 16, 2024, emphasizes the Hong Kong government’s commitment to enhancing healthcare innovation and access. The term of “pharmaceutical products” is defined in the section 2 of PPO. Specific storage conditions, if any. 3. When applying for registration of pharmaceutical products containing NCE, applicants should read these Guidance Notes in conjunction with the <Guidance Notes on Registration of Pharmaceutical Products/Substances>, where applicable. If the product is registered in Hong Kong, please state the Hong Kong Registration Number on the Import/Export Licence. Oct 3, 2024 · 1. Contents include Index Page, Online Functions for Dealers in Precious Metals and Stones ( DPMS ), Create User Account, User Login, Registered Dealers in Precious Metals and Stones, Guidelines, Registering Issues, Enforcement News , Legislation , Online Demonstration, Create User of drugs to promote availability, accessibility, affordability, quality and rational use of medicines. B. For clinical trials that are initiated and conducted by a sponsor-investigator (an individual who is both the initiator and conductor of the clinical trial), whether the clinical trial is submitted under the standard scheme or listed scheme depends on the risk assessment of the clinical trial. Registered Pharmaceutical Products > Search Drug Database. 3974 4180 for general import/export licence application information. The Pharmaceutical Healthcare Association of the Philippines (PHAP), an association comprised of local and multinational Jan 9, 2020 · Pharmacy and Poisons Board of Hong Kong is the statutory body to issue the certificate. Nov 9, 2023 · Following the implementation of the '1+' mechanism for registration of new drugs on November 1, another initiative is the accession of Hong Kong, China to the ICH as an observer so that we can get familiarised with the latest development of drug regulation and take forward the development of the drug regulatory system in Hong Kong. Mar 29, 2019 · Drug Registration Unit . Oct 3, 2024 · Renewal of Pharmaceutical Product Registration. Batch Number. 4 As stipulated under Reg. 138A), "pharmaceutical products" must be registered before they can be sold, offered for sale, distributed or possessed for the purposes of sales, distribution or other use in Hong Kong. 6 million RMB. Comprehending Local Regulatory Guidelines 7. Drug Information and Import/Export Control Division Healthpedia, Radio Television Hong Kong (RTHK) Radio 1 (Chinese only) Health InfoWorld, Radio Television Hong Kong (RTHK) Radio 2 (Chinese only) Staff / Retiree Jul 14, 2021 · (4) whether the existing legislation on new drug registration requires that the registration of a new drug will be approved only if the manufacturer of the new drug owns the relevant drug patents; if so, of the reasons for that; if not, whether the ownership or non-ownership of the relevant drug patent by the manufacturer of a new drug has any Mar 1, 2019 · Drug registration follows American and European requirements. 5. 1, 2020), published by the Oct 29, 2024 · In December 2023, Guangzhou customs authorities reported 155 batches of drugs and medical devices imported from Hong Kong and Macao via the GBA connect scheme, with a total value exceeding 21. Product/Drug Name: Product/Drug Name: Active Sep 21, 2018 · Pharmacy and Poisons Board and be sold in Hong Kong. Retail Trader. S. (*Corresponding author) ABSTRACT As the demand for health supplements rapidly Expert Group on Drug Registration ("Expert Group") on 1 November 2022 for provision of expert opinion on the safety, efficacy and quality of the data submitted by applicants for registration of pharmaceutical products containing a NCE; and advise on matters related to risk management of The Pharmacy and Poisons Board of Hong Kong has endorsed a set of Guidance Documents and new edition of the Codes of Practice for licensed traders with reference to the enhanced regulatory control of Advanced Therapy Products (“ATPs”). HK- HK Registration No. Q. Aug 3, 2023 · The pharmaceutical market in Hong Kong has reached a significant size, estimated to be around $2. In addition, the NMPA will implement a new set of technical review guidelines soon for the applicants to follow when registering their products in future. Notification for Renewal of Registration Certificate; Classification of Products. The Pharmaceutical Healthcare Association of the Philippines (PHAP), an association comprised of local and multinational Nov 9, 2023 · The Hong Kong SAR Government said the accession to ICH as an observer will lay the foundation for it to advance the implementation of the ICH guidelines in Hong Kong so as to strengthen the local capacity of drug approval as well as facilitate software, hardware and manpower development, with becoming an ICH regulatory member as the ultimate goal. The Philippines is no exception and it is currently the fourth largest pharmaceutical market in Asia. Application for registration of pharmaceutical products is made to the PPB, a statutory body to determine whether or not that product is a pharmaceutical product and require to be registered. Additionally, the market has shown a promising growth rate, with a projected increase of 6. Please contact the Drug Information and Import/Export Control Division, Department of Health on Suites 2002-05, 20/F, AIA Kowloon Tower, Landmark East, 100 How Ming Street, Kwun Tong, Kowloon, Hong Kong, or at Tel No. 5% in the coming years. E-mail: hksr@mardep. 0) at DH to shorten the processing time for drug registration approval: As a result of manpower constraints, the processing time for approval of registration of drugs, for change of particulars of registered drugs and for clinical trials are quite long. 138), an ATP must be registered with the Pharmacy and Poisons Board before it can be supplied in Hong Kong. However, in December 2015, after reviewing the regulations in other countries and available scientific information, the Pharmacy and Poisons Board (PPB) decided that these supplements are no longer considered as Guidelines & Forms Drug Registration Import and Export. The applicants will be required to comply with conditions (if any) as imposed on the Certificates of Drug/Product Registration when the applications are approved for registration. 1 In general, the Drug Registration and Import 7 Drug Approval System of Hong Kong (Chemical Products) 1. Navigating the Vietnam pharmaceutical registration process requires a solid grasp of the country’s regulatory framework. 2. Batch number and expiry date (on sales pack and on each ampoule/vial). 138), all pharmaceutical products must be registered with the Pharmacy and Poisons Board before they can be sold or supplied in Hong Kong. The Drug Office of the Department of Health in Hong Kong, responsible for supporting the Board, requires applicants to submit their registration 10 Registration of Biosimilar Products in Hong Kong Consultation with Stakeholders (1) Consultation with different stakeholder groups, including Pharmaceutical trade associations and companies the Hong Kong Association of the Pharmaceutical Industry the Hong Kong Pharmaceutical Manufacturers Association Hong Kong. 2 The EU's regulatory model, characterized by a blend of "centralization" and "decentralization Nov 8, 2024 · List of Pharmaceutical Products Registered Under "1+" Mechanism (as of 8 November 2024) Frequently Asked Questions. Full details concerning the products to be imported or exported such as description, quantity, literature, medicinal/therapeutic uses, product insert, etc should be provided. If your pharmaceutical product is manufactured outside Hong Kong, the person responsible for obtaining registration is the licensed wholesale dealer who imported the pharmaceutical product, or the Hong Kong branch, subsidiary, representative, agent or distributor of the overseas manufacturer. Hong Kong is a good choice for clinical trials because the subjects are Chinese and protocols in English do not need to be translated. gov. Step 1: US FDA OTC Drug Establishment Registration (1 – 2 days) Step 2: Obtaining Labeler code (3 – 5 days) Step 3: OTC Drug Label Compliance (5 – 7 days) Step 4: OTC Drug Listing FDA (3 – 5 days) US FDA OTC Drug Establishment Registration and OTC Drug Listing Steps Jan 1, 2015 · Hong Kong-DH (DEPARTMENT OF Brahmaiah Bonthagarala, The Assesment of Current Regulatory Guidelines for Biosimilars-A Global Scenario, World Journal of Pharmaceutical Research, ISSN 2277-7105 Revised Hong Kong Guide to GMP for the Secondary Packaging of Pharmaceutical Products (July 2024 version) (With effect from 1 July 2025) Guidance for Industry on Secondary Packaging (English Only) Registration as Authorized Person; Application for Registration as Authorized Person; Application for Registration as Authorized Person (e-form) regulatory convergence and work sharing of drug review in Asia. Dec 14, 2022 · (1) given that while the Guidance Notes require that medicines applying for registration in Hong Kong have to obtain beforehand a certificate of registration in two or more designated countries, the Government is currently dividing the places where certificates of registration are issued as set out in the Guidance Notes into two groups (i. 7 The ‘Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee’ (the “Committee”) is established under the Board to issue the Certificate of Drug/Product Registration. Comprehending Local Regulatory Guidelines 15. Press Release Dec 27, 2024 · For example, a well-known U. and/or guidelines. In particular, to enhance the drug regulatory regime, the Hong Kong Special Administrative Region (HKSAR) Government implemented a new mechanism Sep 23, 2024 · In Hong Kong, health supplements, namely vitamins and glucosamine containing products, were once considered as drugs in Hong Kong. 0) Useful Guidelines & Forms : Login to PRS 2. Under the Pharmacy and Poisons Ordinance (Cap. 36(1) of the Pharmacy and Poisons Regulations (Cap. These draft guidelines are based on the trial Guidelines for Real World Evidence to Support Drug Development and Review (Trial) (No. Jan 1, 2015 · Hong Kong-DH (DEPARTMENT OF Brahmaiah Bonthagarala, The Assesment of Current Regulatory Guidelines for Biosimilars-A Global Scenario, World Journal of Pharmaceutical Research, ISSN 2277-7105 Revised Hong Kong Guide to GMP for the Secondary Packaging of Pharmaceutical Products (July 2024 version) (With effect from 1 July 2025) Guidance for Industry on Secondary Packaging (English Only) Registration as Authorized Person; Application for Registration as Authorized Person; Application for Registration as Authorized Person (e-form) regulatory convergence and work sharing of drug review in Asia. Oct 6, 2022 · These draft guidelines apply to communications when real-world evidence is used to support a drug registration application as key evidence to support efficacy and/or safety evaluation. 3 billion. pharmaceutical company recently received approval to begin selling its weight-loss drug in Hong Kong by the end of 2024. 0 System; Terms and Conditions for the Use of PRS 2. hk Enquiry: (852) 2852 4387 Fax: (852) 2541 8842 Mar 1, 2000 · The Asian pharmaceutical market is constantly expanding with Korea, Japan and Taiwan leading the way. e Dec 5, 2024 · Supplementary Information for Drug Registration Guidelines on the Labelling of Pharmaceutical Products Letters Issued by Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee on Labelling of Pharmaceutical Products (Indexed by Date) Feb 9, 2023 · Hong Kong Drug Registration, Patent Linkage, Patent Term Extension, and Bolar Provisions - A taste of “One Country, Two Systems” Davies Collison Cave Hong Kong February 9 2023 May 27, 2024 · Guidelines & Forms >Pharmaceuticals Registration System (PRS2. 4 Are all pharmaceutical products sold in Hong Kong registered?. Drug Registration. Hong Kong Good Manufacturing Practice Guidelines for Proprietary Chinese Medicines: Guidelines for the Trade: 1. The Review Committee recommends that DH shortens the time by 40% - 50%. "Hong Kong Good Manufacturing Practice Guidelines for Proprietary Chinese Medicines" Qualification and Experience Requirements for Key Personnel (Guidelines for the Trade) 2. e. 0 (PRS 2. HONG KONG . 4 . Oct 27, 2021 · Applicant of registration of pharmaceutical products containing new chemical or biological entities (NCEs, i. e Feb 14, 2022 · Hong Kong if: (a) the drug is used for a new indication (different patient population/disease group); or (b) substantial dosage modifications are made for the licensed indication; or (c) the drug is used in combination in which interactions are suspected. The completed application form should be submitted with the supporting documents as Aug 18, 2023 · Vietnam’s Regulatory Framework for Drug Registration. APAC Position Paper covers 6 topics, 2022 (1) consultation, (2) transparency, (3) tracking system, (4) collaborative training, (5) digital tools/platform, and (6) reliance, which have been identified as important areas for refining existing drug registration processes across the APAC authorities around the world. Manufacturer Hong Kong Drug Office has published a guidance note on the registration of pharmaceutical products containing a new chemical or biological entity (NCE) in August 2021. C. 3/F, Public Health Laboratory Centre, 382 Nam Cheong Street, Shek Kip Mei, Kowloon (Enquiries by telephone: 2319 8458) 6. A. APAC Position Paper covers 6 topics, 2022 (1) consultation, (2) transparency, (3) tracking system, (4) collaborative training, (5) digital tools/platform, and (6) reliance, which have been identified as important areas for refining existing drug registration processes across the APAC Mar 29, 2019 · Drug Registration Unit . In addition to the supporting documents as specified in Table 1, other relevant Jan 22, 2021 · Otherwise, if the combination product intends to achieve a drug effect on the patient, the applicant shall meet the registration requirements of a drug product in China. Drug Registration and Import/Export Control Division . 138) Supplementary Information for Drug Registration. May 27, 2024 · Registered Pharmaceutical Products. “Pharmaceutical product” means any substance, or combination of substances. Name of preservatives, if any. May 27, 2024 · Useful Guidelines & Forms : Notification for Renewal of Registration Certificate; Questions and Answers on PIC/S GMP Requirements for Registration of Imported Pharmaceutical Products; Request Form for Drug Office GMP Inspectors to Conduct Inspections of Overseas Manufacturers Jul 15, 2024 · Preclinical research is a critical step in the drug approval process in China. 7. Looking ahead, the Hong Kong government plans to establish its own drug approval authority within the next 8-10 years, further enhancing its autonomy in the drug registration process. SHIP REGISTRATION GUIDELINES (October 2024 version) Hong Kong Shipping Registry Room 302, 3/F, Harbour Building, 38 Pier Road, Central, Hong Kong. registration certificate holder. The registered products not only provide safe Chinese Medicine products to the public, but also have driven ancillary economic activities and created MiV-PA8 Change of the specification of drug substance 21 MiV-PA9 Change of the test procedure of non-compendial drug substance 21 MiV-PA10 Change of shelf-life or retest period for drug substance 22 MiV-PA11 Change of storage condition for drug substance 22 MiV-PA12 Revision of European Pharmacopoeial Certificate of Suitability Drug News; Useful Guidelines; Introduction to Drug Regulatory System in Hong Kong; Press Release “Pharmacies” in Hong Kong; Differences between pharmacy and medicine store ; Frequently Asked Questions ; List of registered pharmaceutical products indicated for the treatment or prevention of coronavirus disease (COVID-19) Drug Registration Unit Drug Registration and Import/Export Control Division Drug Office Department of Health 3/F, Public Health Laboratory Centre, 382 Nam Cheong Street, Shek Kip Mei, Kowloon (Enquiries by telephone: 2319 8458) 6. Mar 9, 2021 · In Hong Kong since registration of Proprietary Chinese Medicines took effect in 2003, more than 2,400 Proprietary Chinese Medicines products have been issued a certificate of registration . Registered Pharmaceutical Products : List of Registered Pharmaceutical Products As stated in A1, ATP falls within the definition of pharmaceutical product. Registered ATP should be labelled with the Hong Kong registration number, in the form of "HK-XXXXX", on its container. 4. Hong Kong registration number of the product. Under the Pharmacy and Poisons Ordinance (PPO) (Cap 138), the PPB considers drug registration by investigating scientific data criteria in relation to safety, efficacy and quality. 1 The Drug Office of the Department of Health provides executive and professional support to the Pharmacy and Poisons Board. Dec 1, 2024 · Since the implementation of Directive 2004/24/EC, the European Union (EU) has gradually developed a comprehensive regulatory system for Herbal Medicinal Products (HMPs), ensuring effective governance across member states and exerting a significant influence on global herbal market regulations. Registered drugs in Hong Kong are subject to a mixture of random and risk-based sampling for chemical, microbiological (for sterile products only) Jan 7, 2025 · Dealers in Precious Metals and Stones Registration System provided by the Hong Kong Customs and Excise Department. - HK- HK Registration No. Pharmaceutical products may include chemical or ‘biological’ materials as active ingredients or substances. 0) at Nov 15, 2021 · 3. Guidance Notes on Classification of Products as "Pharmaceutical Products" under the Pharmacy and Poisons Ordinance (Cap. 2 If your pharmaceutical product is manufactured outside Hong Kong, the person responsible for obtaining registration is the licensed wholesale dealer who imported the pharmaceutical product, or the Hong Kong branch, subsidiary, representative, agent or distributor of the overseas manufacturer. HONG KONG SHIPPING REGISTRY. Dec 7, 2024 · US FDA OTC Drug Registration Steps. Dec 11, 2024 · "The Chief Executive's 2024 Policy Address" has proposed a number of initiatives to improve the drug approval mechanism so as to speed up registration and facilitate good drugs for use in Hong Kong. Additional Labelling Requirements for Certain Classes If your pharmaceutical product is manufactured outside Hong Kong, the person responsible for obtaining registration is the licensed wholesale dealer who imported the pharmaceutical product, or the Hong Kong branch, subsidiary, representative, agent or distributor of the overseas manufacturer. This phase involves extensive laboratory testing and animal studies to assess the basic safety and biological activity of a new pharmaceutical compound. Drug Information and Import/Export Control Division. The registration certificate holder should submit online application for change of registered particulars (CORP) to the Drug Office via the Pharmaceutical Registration System 2. Video clips on safe use of drugs “Pharmacies” in Hong Kong; Guidelines & Forms; Extending the “1+” mechanism for Registration of Pharmaceutical Mar 15, 2023 · (3) of the respective numbers of applications for registration of new drugs from those four places which have been received, approved and rejected by the Board since the drug regulatory authorities in the aforesaid four places were added to the list of specified reference places; the justifications for rejecting the applications; whether the May 27, 2024 · Registered Pharmaceutical Products. Expiry date. This includes six previously approved batches of medical products, highlighting the region’s ongoing efforts to enhance healthcare access. 15. You should hand in the completed application form to the Drug Registration Unit along with: (A) the Application Fee, currently at $1,100 (Please also see paragraph 14); (B) the Checklist (Appendix 1) duly completed; (C) for products manufactured outside Hong Kong, an authorization letter from Overview of Health Supplement Regulations in Hong Kong: A Comparison with Drug Regulations LEE, Benny Chi Waia; CHONG, Donald Wing Kita*; CHAN, Stephanie Nok Yana a Haleon Hong Kong Limited, Unit 2810-2812, 28/F, AIRSIDE, 2 Concorde Road, Kai Tak, Hong Kong SAR, China. Additional Labelling Requirements for Sterile Products 1. In particular, to enhance the drug regulatory regime, the Hong Kong Special Administrative Region (HKSAR) Government implemented a new mechanism HONG KONG . 6. In 1999 alone, the Filipino pharmaceutical market saw a 5% increase. contain active ingredients which have not been registered in Hong Kong) is required to provide documents as stated in the "Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity" (Note Drug registration process is getting vigilant in Hong Kong and the manufacturer needs to submit additional information, such as, documents to support the information in the expert evaluation reports on safety and efficacy; Information on worldwide registration status of the product, including withdrawal or refusal; licensing conditions imposed Oct 30, 2024 · Supplementary Information for Drug Registration Guidelines on the Labelling of Pharmaceutical Products Letters Issued by Pharmacy and Poisons (Registration of Pharmaceutical Products and Substances: Certification of Clinical Trial/Medicinal Test) Committee on Labelling of Pharmaceutical Products (Indexed by Date) Nov 15, 2021 · 3. In Hong Kong, it is the Government’s public healthcare policy that no one should be denied adequate medical treatment through lack of means. Guidelines on the Labelling of In Hong Kong, medicines are required to be registered under the Pharmacy and Poisons Ordinance Cap 138. 2 Tasks1) The divisions under the DO are summarized as follows: Pharmacovigilance and Risk Management Division: Responsible for the Jun 1, 2023 · A Q&A guide to life sciences regulation in Hong Kong. 1. The Hospital Authority (HA) Ordinance The Pharmacy and Poisons Board of Hong Kong has endorsed a set of Guidance Documents and new edition of the Codes of Practice for licensed traders with reference to the enhanced regulatory control of Advanced Therapy Products (“ATPs”). In the Hong Kong context, DH has been utilizing the following channels to identify hazards related to drug safety. Previously, applicants for new drug registration had to provide documentation of two reference country approvals for evaluation. Questions and Answers on PIC/S GMP Requirements for Registration of Imported Pharmaceutical Products; Request Form for Drug Office GMP Inspectors to Conduct Inspections of Overseas Manufacturers; General Requirements for Master Formula and Specifications for Non-Biological Products Feb 23, 2022 · pharmaceutical products in Hong Kong, which include the following Ordinances and their relevant subsidiary legislation: Pharmacy and Poisons Ordinance (Chapter 138); Antibiotics Ordinance (Chapter 137); Dangerous Drugs Ordinance (Chapter 134); Undesirable Medical Advertisements Ordinance (Chapter 231); pharmaceutical products in Hong Kong, which include the following Ordinances and their relevant subsidiary legislation: • Pharmacy and Poisons Ordinance (Chapter 138); • Antibiotics Ordinance (Chapter 137); • Dangerous Drugs Ordinance (Chapter 134); • Undesirable Medical Advertisements Ordinance (Chapter 231); Jan 26, 2017 · Under the Pharmacy and Poisons Regulations, pharmaceutical products must be registered with the Pharmacy and Poisons Board before they can be sold, offered for sale, distributed or possessed for the purposes of sale, distribution or other use. By obtaining the necessary licenses, ensuring product registration, adhering to labeling standards, and complying with international guidelines, pharmaceutical companies can successfully enter Jun 3, 2024 · Under Hong Kong’s Pharmacy and Poisons Ordinance (Cap. Hong Kong is a part of the Pharmaceutical Inspection Cooperation Scheme, which brings a high standard of drug regulation. yaymkriv nlxiasyy wwqmcn frdv sgxqx ett fxtb oaqr vhufcx ehb