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As part of providing a smooth regulatory process for cell, tissue, and gene therapy products (CTGTP) dealer’s notice and class 1 CTGTP notification, HSA presents a one-stop digital portal SHARE (Singapore Health Product Access and Regulatory E-System) and will be officially launched on 2 January 2024. Hence, starting from the launching date, all new dealer notices or product notification submissions, updates, or active status checking can be made directly in the SHARE portal by using the company’s Corppass Administrator. HSA will continue to process new submissions of the CTGTP Dealer’s Notice or Class 1 CTGTP Notification via FormSG until 31 December 2023 and any update submissions for CTGTP Dealer’s Notice or Class 1 CTGTP Notification via FromSG will be accepted until 18 December 2023. Beyond the mentioned dates, all matters are required to be submitted directly to the SHARE portal starting from 2 January 2024. All existing data will be transferred to the SHARE portal and no actions required to be done by the companies. Further, no regulatory or submission requirements changes are to be implemented to the existing active companies. Source: Health Sciences Authority (HSA) Contact us at info@arqon.com for more information.

Australia will be under a new reformation for vaping and is expecting amendments to the Therapeutic Goods Act 1989 to be introduced throughout 2024. The new regulations will undergo 3 stages commencing from 1 January 2024. The government outlined stringent enforcement initiatives to prevent nicotine addiction among younger generations and to address public health issues related to harm caused by vapes. Important dates to be noted as below: 1 January 2024 Banning the importation of disposable single-use vapes (except for very limited exceptions) Special Access Scheme pathways for medical practitioners to prescribe therapeutic vapes for nicotine dependence management patients or smoking cessation patients 1 March 2024 Banning implemented to the importation of all non-therapeutic vapes, irrespective of nicotine content, and therapeutic claims Banning implemented for the personal importation of therapeutic vapes Pre-market notifications to the TGA are required for importers and domestic manufacturers of therapeutic vapes to declare goods compliance before the importation or goods supply Importers are required to obtain custom licenses and permits from the Australian Government’s Office of Drug Control TGA will provide forms and guidance to notify compliant products Therapeutic vapes will be strictly controlled with new product standards which are; limited flavours, permissible nicotine concentration reduction, pharmaceutical packaging TGA advises all manufacturers, importers, wholesalers, and retailers of therapeutic vapes, non-therapeutic vapes, and disposable single-use vapes, to comply with the pre-market notification, or, advised to reduce or sell off stocks before the reformations commence. Source: Therapeutic Goods Administration (TGA) and Department of Health and Aged Care Contact us at info@arqon.com for more information.

According to Regulation (EU) 2017/745, manufacturers are required to assign a Unique Device Identification (UDI) before placing their devices in the market, except for custom-made devices. Each UDI consists of a Unique Device Identification-Device Identifier (UDI-DI) and a production identifier (UDI-PI) and these data were assigned specifically to the devices’ model and manufacturer. Contact lenses are known for many variants due to the high number of clinical parameters and many UDI-DI were generated for almost similar contact lenses. Hence, the individualized UDI-DI as regulated under Regulation (EU) 2017/745, had caused system overwhelm, proliferation of the UDI-Dis, and disproportionation when contrasted with the safety risk of the contact lenses. Therefore, an amendment was decided to prevent different DI assigned to similar contact lenses and shall be implemented starting from 9 November 2025: Standard contact lenses A UDI-DI shall be assigned to the standard contact lenses under the same combination of contact lens design parameters, including at least the base curve and diameter (“Master UDI-DI”) A new Master UDI-DI shall be required if there are any changes in the combination group Made to order contact lenses A UDI-DI shall be assigned to the standard contact lenses under the same combination of contact lens design parameters, including at least the base curve and diameter (“Master UDI-DI”) A new Master UDI-DI shall be required if there are any changes in the combination group The European Commission encourages manufacturers to start implementing the Master UDI-DI according to the amended regulation. Source: European Commission (EC) Contact us at info@arqon.com for more information.

The Ministry of Health of Vietnam (MOH) has taken a step forward in simplifying the registration and circulation of drugs and medicinal ingredients efficiently. On 19th November 2023, MOH proposed to revise a number of articles under Pharmacy Law for amendment and supplementation. - Clause 2, Article 54: The proposed amendment is to shorten the registration process for medicinal ingredients that have been used to produce drugs with registration certificates for circulation in Vietnam. - Clause 6, Article 56: No further extension is given for the circulation registration certificate of drugs and medicinal ingredients that have not been circulating within the validity period granted. - Clause 2,3,4, Article 55 & Clause 1,3,5,6 Article 56: Simplify the extending, changing, and supplementing procedures and dossiers for Registration Certificates. Suggesting to shorten the renewal period for Circulation Registration Certificate (3 months shorten to 1 month). The extension submission for the Circulation Registration Certificate should be done 6 months prior to the expiry date. - Clause 2, Article 56: Allows replacement for the Certificate of Pharmaceutical Products (CPP) with other authorized or licensed documents as solid evidence during critical needs (national defenses, disease prevention and control) Approve the results of an appraisal of the technical and clinical dossiers for drug registration dossiers and GMP certificates for the finished drug manufacturing facilities for new drugs licensed for circulation in foreign countries with the authorized agency, EMA. Exemption of clinical dossier submission of the new drug that is developed locally for critical needs, with the same active ingredients, and dosage form, and has been licensed for circulation by any of the authorized authorities during the submission of the Circulation Registration Certificate application. Overall, MOH will be able to reduce administrative tasks for the registration and circulation of drugs and medicinal ingredients and smoothen the procedure during the critical period, for instance during the disease pandemic. Furthermore, an efficient procedure may attract local and foreign manufacturers to establish new drug development in Vietnam’s market. Source: Ministry of Health of Vietnam (MOH) Contact us at info@arqon.com for more information.

As we are approaching 1 January 2024 in 6 weeks’ time, that means the EC Decision Reliance Procedure (ECDRP) will be replaced by the International Recognition Procedure (IRP). So, all applications for new medicines will be authorized under the IRP. An online tool, “Eligibility Checker” has been developed to smoothen the procedure of bringing life-saving medicines to UK patients via the International Recognition Procedure (IRP). Starting from 20 November 2023, all involved applicants are advised to utilize the tool in order to ensure the eligibility of their Marketing Authorization Applications (MAAs) for the IRP and determine the suitability of routes offered (Route A or Route B). Completing the Eligibility Checker (initial MAAs only) Applicants have to obtain the 5-digit company number and the product license (PL) number before completing the Eligibility Checker. The PL number can be requested from PLNumberAllocation@mhra.gov.uk while the 5-digit company number should be obtained from Reference.data@mhra.gov.uk. The route recognition suitability will be determined once the Eligibility Checker is completed 6 weeks before the MAA submission planned date. Requirements for Submitting a Completed Eligibility Checker Applicants are required to read the IRP guidance and answer the series of questions in order to assist MHRA in classifying the appropriate IRP route for submission. Triage might be required in some cases. Applicants should take note of the information below: Recognition A eligibility criteria: RR approval must be granted within the previous 2 years Recognition B eligibility criteria: RR approval must be granted within the previous 10 years Submission Procedure for Completed Eligibility Checker Form Source: Medicines and Healthcare products Regulatory Agency (MHRA) Contact us at info@arqon.com for more information.

On the 390th meeting on the 3rd of November 2023, the National Pharmaceutical Regulatory Authority (NPRA) agreed to update the Guideline for Facilitated Registration Pathway (FRP), Revision 1, 2023 and will be enforced effectively from 1 January 2024. The revision was decided to align the Guideline FRP for pharmaceutical-related products that have been approved by the WHO Collaborative Registration Procedure (CRP) or assessed by the ASEAN Joint Assessment (AJA). As previously in 2020 and 2022, NPRA representing Malaysia joined WHO CRP for Products Authorized by WHO Stringent Regulatory Authorities (SRAs), WHO prequalified (PQ) medicines and vaccines, ASEAN Joint Assessment (AJA) for joint product evaluation, and chaired the AJA Coordinating Group (JACG), the rollouts were important to ensure NPRA is competent and efficient in providing thorough services. Furthermore, NPRA approved the addition of the Health Canada (Canada), Pharmaceuticals and Medical Devices Agency (PMDA - Japan), Swissmedic (Switzerland), Therapeutic Goods Administration (TGA - Australia), and Medicines and Healthcare products Regulatory Agency (MHRA – United Kingdom) into the approved reference authorities. This initiative helps to shorten the assessment period and increase the volume of the products to be assessed via the FRP procedure at once. Among the revised aspects in the Guideline FRP can be referred to below: Product scope expansion: Covering new drug products, generic medicines, and biologics including cell and gene therapy products (CGTPs) Addition reference authorities for procedures as stated above Abbreviated Review for WHO CRP & all products that have been approved by the stated reference authorities above Verification Review applicable for ASEAN Joint Assessment Submission of the application period to NPRA from the approval date by the reference authorities is extended to 3 years The revision timeline for the Abbreviated Review was shortened to 90 working days and the Verification Review shortened to 30 working days All product registration holders should be alert to the important changes and dates to avoid product disruption in the market. For more details on the updated guideline, can refer here (Guideline for Facilitated Registration Pathway (FRP), Revision 1, 2023) Source: National Pharmaceutical Regulatory Authority (NPRA) Contact us at info@arqon.com for more information.

Commencing 18 October 2023, BICON – Department of Agriculture, Fisheries, and Forestry of Australia decided to implement the new adjustment on the importation requirements of the retail packaged cosmetics and soaps for non-personal human use, allowing for a maximum of up to 20% animal-derived materials by mass. The responsible person should note the requirements below for the cosmetics and soap products entering the Australian market: Ensuring the imported products are for human use only Confirmation statements prove that the products contain less than 20% animal-derived materials by mass, excluding the approved materials of animal origin Confirmation statements that the products have been prepared and packaged for commercial purposes Confirmation statements that the products are prepared for retail sales and do not require further processing The confirmation statements above are required to be attached together with the Manufacturer’s or Supplier’s declaration. These changes intend to smoothen the trading transactions and standardize the processes of importing cosmetics and soaps. Source: Department of Agriculture, Fisheries, and Forestry Contact us at info@arqon.com for more information.

In the previous blog (USA: FDA Drafts Guidelines for Facilities Registration and Listing of Cosmetic Products), we discussed the new FDA authorities authorized under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) for cosmetics facility registration and product listing requirements. The responsible persons were required to submit the marketed cosmetic product information listing to the FDA, register the facilities with the FDA within 60 days of any changes, and apply for the registration renewal for every 2 years. Upon this enactment, MoCRA issued a statutory deadline for industries to commit which was 29 December 2023. However, on 8 November 2023, the FDA announced the postponement of the enforcement of the deadline, until 1 July 2024, after receiving concerns from the industry representatives on the ample time needed to prepare for the facility registration and product listing, including obtaining the facility registration numbers that associate with the product listing. Hence, FDA extends the enforcement to 6 months so that industries are able to prepare the requirements. Source: Food and Drug Administration (FDA) Contact us at info@arqon.com for more information.

Commencing efficiently from 1 November 2023, the Pharmacy and Poisons Board will be implementing the new “1+ mechanism” to facilitate the pharmaceutical product registration containing new chemical or biological entities (NCE products), for life-threatening or severely-debilitating diseases. Previously according to the “Guidance Notes on Registration of Pharmaceutical Products Containing a New Chemical or Biological Entity”, the applicants were mandated to present proof documentation demonstrating the approval of the product registration from two or more drug regulatory authorities of the reference countries. However, through the 1+ mechanism, applicants who are not able to provide official proof of registration approval from two or more authorities of the listed reference countries, are still allowed to proceed with the new drug registration, under the condition that: There is a local unmet medical need for a life-threatening or severely debilitating disease products The product is approved with orphan drug designation, breakthrough therapy designation, priority review designation, and marketed in any of the reference countries There are local clinical data, clinical studies, or case reports of the product related to the proposed indication Apart from the proof of the approval documentation, applicants were also obligated to fulfill the other requirements for NCE product registration under the 1+ mechanism: Justifications for non-compliance with the registration requirement for approval of a minimum 2 reference countries and proof documentation proving that the products fulfill the mechanism requirements Assessment reports by a local expert, with at least 5 years experience in the relevant field of the products, or equivalent, including the review of the following: o The local and global epidemiology of the disease o The local and international treatment paradigms of the disease o Local unmet medical needs of the disease o Safety and efficacy of the product o Evaluation report of the clinical data The assessment report, post-authorization requirements, or/and licensing condition issued by the drug regulatory authority that granted the product approval in the reference country Periodic safety update report, summary safety report Post-registration development plan Reference countries recognized by Hong Kong Drug Office: Australia, Austria, Belgium, Brazil, Canada, China, Finland, Ireland, Japan, Polan, Singapore, Sweden, Switzerland, UK, USA Source: Drug Office, Department of Health Contact us at info@arqon.com for more information.

The National Health Regulatory Authority (NHRA) released Circular No. (26) 2023, on the revision of Resolution 32 regarding the fast-track registration procedures for pharmaceutical products. In the statement released, NHRA mentioned 2 fast-track procedures prepared for product registration involving a 10-day registration procedure and a 20-day registration procedure. 10-Day Registration Procedure This registration procedure is subjected to pharmaceutical products that are to be registered/approved by one of the reference authorities below: Gulf Cooperation Council Central (GCC Central) Saudi Food and Drug Authority (SFDA) US Food and Drug Authority (US FDA) European Medicines Agency (EMA) SwissMedic Medicines and Healthcare Products Regulatory Agency (MHRA) The Batch-Releasing site should be registered with NHRA together with the above-mentioned authorities Full e-CTD dossier of the product registration, same as registered in the above-mentioned authorities, together with a complete assessment report. Declaration letter from the marketing authorization holders (MAH) to clarify all information is correct and as approved by the above-mentioned authorities. 20-Day Registration Procedure This procedure is subjected to the pharmaceutical products that are not registered with any of the above-mentioned reference authorities. MAH should note after completing the full e-CTD dossier submission for intended product registration, a Signed Checklist will be given by the New Registration team. The intended registered products are not required to be registered in one of the reference authorities, but the Batch Releasing site is required to be registered in one of the reference authorities. License will be issued for 1 year and registration requirements are expected to be completed within the period. If the requirements are not completed, the conditional registration will be inoperative and products will not be registered without any notification. While 4 additional years will be given if MAH manages to complete the registration requirements within the 1-year period. Source: National Health Regulatory Authority (NHRA) Contact us at info@arqon.com for more information.

Effectively from 1 October 2023, the Medical Device Authority (MDA) ceased the issuance of Certificate of Free Sale (CFS) for export-only medical devices, instead the CFS issuance is applicable only for registered medical devices. CFS for export-only (CFS-EO) medical devices that have been issued before the effective date of the Export Certificate, are valid until the expiration date. According to the Circular Letter of Medical Device Authority No.4 Year 2018, medical devices for export only were exempted from the registration requirements under the Medical Device Act 2012 (Act 737) but required to submit notification to the Authority. The exportation activities were only allowed once the Authority issued the Export Only Medical Device Exemption Letter. With that, MDA will release an Export Certificate to facilitate the export activity, including registration/importation procedures for export-only medical devices from Malaysia to foreign countries. Exporters should note that this certificate is not a mandatory requirement from MDA. Application Process Exporters are required to acquire an Export Only Medical Device Exemption Letter before proceeding to apply for an Export Certificate. Turn-around time for the process with complete documentation is 14 working days. The required supporting documents are: Export certificate application form Export Only Medical Device Exemption Letter by MDA Medical Device list Medical device label (provided accordingly to the importing country information as stated in the application form) Attestation Issuance of Export Only Medical Device Exemption Letter MDA will issue the Export Only Medical Device Exemption Letter within 14 days upon completed payment, via email and letter. The period validity for the letter is five (5) years and allows for multiple export consignments. No exportation activity to the medical devices stated in the letter is allowed once the exemption letter reaches the expiration. Source: Medical Device Authority (MDA) Contact us at info@arqon.com for more information.

The Federal Council of Switzerland decided to regulate the changes in the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Devices (IvDO) involving non-medical purpose products that have comparable functions and risk profiles to medical devices. This regulation will officially be enforced starting from 1 November 2023. This provision is intended to enhance the safety of non-medical purpose products which are mainly used in cosmetics, cosmetic surgery, bodyforming, and interventional psychiatry and opticians. On the other hand, the Federal Council would like to adapt these product groups into the medical device law. Please refer to the list below for the details of the non-medical purpose product groups: Contact lenses, or other items intended to be introduced into or onto the eye Products designed for surgical insertion, either partially or totally, into the human body, to alter or affix body parts (except tattoo products and piercings) Substances, the combination of substances, items intended to be used for facial, dermal, or mucous membrane filling by subcutaneous, sub-mucous, or intradermal injection, or other introduction (except tattooing) Devices with the purpose of reducing, removing, or destroying adipose tissue (Example: devices for liposuction, lipolysis, or lipoplasty) Devices that emit high-intensity electromagnetic radiation with the purpose of use on the human body (example: infra-red, visible light, ultraviolet), including coherent and non-coherent sources, monochromatic and broad-spectrum for skin resurfacing, tattoo, or hair removal, or other skin treatment (example: lasers, intense pulsed light equipment) Brain stimulation purpose devices that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain Further updates on the implementation guides and specifications will be continuously updated by Swissmedic for the non-medical purpose product groups. Source: Swissmedic Contact us at info@arqon.com for more information.