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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.

Taiwan Food and Drug Administration (TFDA) updated the pharmaceuticals enforcement including the pharmaceutical firm types, requirements, methods, and schedules regulated under “Western Pharmaceuticals Good Distribution Practice (GDP) Regulations”. Pharmaceuticals and Pharmaceutical Firms who implemented Western Pharmaceuticals Good Distribution Practice Regulations are obligated to obey the following official announcements from the Ministry of Health and Welfare: 11 September 2018: Implementation Items and Schedules for the Western Pharmaceuticals Good Distribution Practice Regulations” 10 May 2019: Pharmaceuticals and the Types of Pharmaceutical Firms, Requirements, Methods, and Schedules Regulated under ‘Western Pharmaceuticals Good Distribution Practice Regulations – Western Pharmaceuticals Requiring Cold Chain Storage and Transportation’ 27 July 2020: Pharmaceuticals and the Type of Pharmaceutical Firms, Requirements, Methods, and Schedules Regulated Under ‘Western Pharmaceuticals Good Distribution Practice Regulations – Active Pharmaceutical Ingredients’ Any pharmaceuticals, and pharmaceutical firms that have not implemented the Western Pharmaceuticals GDP Regulations yet, shall obtain the Western Pharmaceuticals distribution license, (I) By 30 June 2024, if : The pharmaceuticals or pharmaceutical firms obtained the authorization of importation/exportation of western pharmaceuticals with the western pharmaceutical permit license, or, The pharmaceutical firms run wholesale activity of plasma derivatives, vaccines, or botulinum toxins that do not require cold chain storage and transportation (II) By 31 December 2024, if : The pharmaceutical firms run the wholesale activity of pharmaceutical products other than plasma derivatives, vaccines, or botulinum toxins The pharmaceutical firms run the wholesale activity of western pharmaceutical products stated in Paragraph 2, Article 3, Controlled Drugs Act The pharmaceutical firms run the wholesale activity of pharmaceutical products referred to Article 27-2 of the Pharmaceutical Affairs Act (III) By 31 December 2025, if : The pharmaceutical firms run the wholesale activity medicines to be prescribed by physicians of, referred to Paragraph 2, Article 8, Pharmaceutical Affairs Act and Article 3 of Enforcement Rules The pharmaceutical firms supply western pharmaceutical products to more than 10 wholesale dealers from 1 October 2024 until 31 December 2024 (IV) By 31 December 2026, if the pharmaceutical firms are involved in the activity of wholesaling, importing, or exporting the western pharmaceutical products that are not stated above. (V) The western pharmaceutical distribution license applied from the aforementioned firms is accepted starting from the announcement date. Kindly remember that the distribution license issuance will be subjected to the inspection of the quality system by the central competent health authority. Source: Taiwan Food and Drug (TFDA) Contact us at info@arqon.com for more information.

COFEPRIS decided to modify the Official Mexican Standard (NOM) 177 in order to facilitate the registration of generic and biosimilar medicines in Mexico. The announcement that was made on 28 September 2023 explained that COFEPRIS will start to recognize clinical studies conducted from outside countries, as long as the country qualification is higher than Mexico or certified as reference bodies by the World Health Organization (WHO). This modification benefited both foreign manufacturers and local companies who obtained manufacturing and marketing licenses for pharmaceutical products. Mexico shows good initiative to streamline the local registration requirements and international standards. As the regulatory facilities are rapidly developing, this initiative may support the expansion and improve the therapeutic products demands from Mexico. However, in the meantime, the clinical studies results conducted in the country are still required as the registration requirement for biosimilar medicines. Source: Federal Committee for Protection from Sanitary Risks (COFEPRIS) Contact us at info@arqon.com for more information.

On 29 September 2023, the Health Science Authority (HSA) of Singapore published the decision from the initial communication with stakeholders on the GMP evidence requirement for chemical drug substance (DS) manufacturers. In order to orient the GMP requirements for chemical and biologics DS manufacturers, starting from 1 October 2024, HSA will fully regulate the GMP evidence requirement for drug substance (DS) manufacturers. As for now, a 1-year transitional period is given for companies adapting to the requirement. The implementation is applied to New or Generic Drug Applications (NDA/GDA) and Minor Variation Applications (MIV-1) for the addition of a new DS manufacturer. Any applications submitted on or after 1 October 2024 not complying with the requirement will be rejected. Listed below are types of GMP Compliance Evidence that can support the application submission: Valid GMP certificate issued by PIC/S authority. Companies can attach the GMP inspection report together with the close-out letter, or, authority evidence such as manufacturing license that proves the site complies with PIC/S GMP requirements if the PIC/S authority does not issue GMP certificate. Note that: GMP Evidence must cover the DS of interest Valid Active Pharmaceutical Ingredient (API) Registration Certificate, that covers the DS of interest, listed in the EUDRAGMP Valid Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) for the DS of interest issued by EDQM Companies are suggested to start attaching the GMP evidence from now until 30 September 2024, for a smooth transition process and adapt to the actual enforcement. The implementation will ensure the quality of therapeutic products supplied in Singapore is in the finest condition. Source: Health Science Authority (HSA) Contact us at info@arqon.com for more information.

­Previously on 10 April 2023, Anvisa regulated a simplified registration route for microbiological products under Joint Ordinance SDA/MAPA – IBAMA – ANVISA No.1 of April 10, 2023. The establishment applies to microbiological products used as pesticides, defoliants, desiccants, stimulants, or growth inhibitors with qualitative and quantitative composition and isolated microorganisms equivalent to reference products for which the analysis of potential environmental hazard, potential human health hazard, and agronomic efficiency has been completed. In order to enhance efficiency and reduce processing time, Anvisa created a new subject code for microorganism product registration that is listed under the simplified registration route, which is 5141 – Microbiological Product – simplified registration route. Anvisa will separate the registration request based on the subject code, even if no technical analysis is required for the products. Interested sponsors may submit the registration or re-evaluation registration request of the microbiological products to each of the responsible authorities, Ministry of Agriculture and Livestock, Anvisa, and Ibama, within 5 working days from the first filing. However, the simplified registration application of the biological products must be evaluated only by the Ministry of Agriculture and Livestock (MAPA). Source: National Health Surveillance Agency (Anvisa) Contact us at info@arqon.com for more information.

Health Products Regulatory Authority (HPRA) released a new application form for the free sale certificates for medical devices qualifying under Regulation 2023/607. All certificates now have been certified together with their expiry dates. For a free sale certification application from HPRA for devices qualified under Regulation 2023/607, the responsible person has to complete and submit the new form together with other documentation which is: Declaration of conformity Manufacturer self-declaration letter Proof of payment Device schedule Authentication letter of the manufacturer’s physical site For devices that are not qualified under Regulation 2023/607, the application of a free sale certificate can be applied by submitting the existing MDD/AIMDD application form together with the required documents as above. Referring to Regulation 2023/607 that was enforced on March 2023, devices that qualify for the MDR transitional period extensions under the regulation are; Class I up classified devices, Class Im devices, Class Is devices, Class IIa and IIb devices, Class IIb implantable devices, Class III implantable devices, and Class III custom-made devices. HPRA stipulated the certificates’ expiry date for qualified devices would be 3 years from the issuance date, while for the non-compliance devices, the expiry date would be May 2024. All stakeholders are encouraged to engage with the requirement to prevent market disruption. Source: Health Products Regulatory Authority (HPRA) Contact us at info@arqon.com for more information.

The National Medical Products Administration (NMPA) announced the implementation of the requirements of toothpaste regulatory regulations and the simplification of filing requirements for toothpaste on the market. Firstly, NMPA emphasizes the responsibilities of the filing person (toothpaste filer) should be an enterprise or an established organization complete with a quality management system and adverse reaction monitoring and evaluation system. Starting from 1 December 2023, prior to being marketed or imported, domestic toothpaste is required to be registered under the provincial drug regulatory department, where the recorder is located, and the imported toothpaste must be registered with the State Food and Drug Administration. The responsible toothpaste filer, specifically for the first-time registration filer, should note the requirements: For the first-time product to be registered, the filer is required to submit registration information via the toothpaste registration information service platform that has been designed by the registration management department. To be responsible for the safety, quality, efficacy claims of the toothpaste, integrity, authenticity, and traceability of the product registration materials and data. To upload and publish the summary of the product efficacy evaluation data on the efficacy claims on the filing platform and must respond to accept for social supervision. However, this requirement is exempted for toothpaste with the claim of cleaning effects only. Ensuring the children's toothpaste claimed suitable for under 12 years old (including 12 years old) provide claims only for cleaning and caries prevention, marked with the children’s toothpaste logo (“Children’s Toothpaste”) on the sale packaging, and marked with relevant warnings (“Use under adult supervision”, “Not edible”, “Beware of swallowing”) Next, for the safety risks assessment, starting from 1 October 2023 until 30 November 2023, toothpaste filers can submit the following simplified information for toothpaste that has been on the market: The toothpaste filer information (name, address, contact information) The assigned production information (name, address, contact information) Product information (product name, product formula, product sales packaging label pictures) Relevant information confirming the safe use history of the product (production input records, material records, sales invoices, inspection reports) In the case of toothpaste products whose first batch was sold in the market prior to 1 January 2021, the filer may keep the product registration documentation on file for future use. Otherwise, the filer must upload complete filing documents via the filing platform. For toothpaste products with simplified filling, the labeling must adhere to the "Measures for the Administration of Cosmetic Labels" and any labeling revisions must be made before 1 July 2024. The product registration materials and summary of the product cleaning efficacy claims must be completed, uploaded, and published before 1 December 2025. All responsible persons are advised to be prepared with the requirements and note the important dates to prevent market disruption. Source: National Medical Products Administration (NMPA) Contact us at info@arqon.com for more information.

Ministry of Public Health (MOPH) released Circular NO (DHP/2023/100) on 12 September 2023 extending the commission by Ministerial Resolution No. (4/2020) on ensuring the quality and safety of Implanted Medical Devices (IMD) distributed in Qatar are secured by the Primary Source Verification (PSV) process. Starting from 1 October 2023, all manufacturers, distributors, and representatives for IMD are required to undergo the Primary Source Verification process by obtaining Credentials from DataFlow in order to submit for authenticity verification of the registration application documents. So, only the verification reports licensed by DataFlow are accepted, not from the notarization or attestation process. The IMD registration documents that are subjected to the authenticity verification process are: Manufacturer registration certificate CE or FDA certificates from the country of origin, including IMD reference codes Free Sale Certificate (FSC) from the country of origin, including IMD reference codes All responsible manufacturers, distributors, and representatives involved with the implanted medical devices activity in Qatar are advised to pay attention to the new regulatory requirements. Please click on the link below to view the process details. Source: Ministry of Public Health (MOPH) Contact us at info@arqon.com for more information.

As regulated in Subsection 7 (1) of the Therapeutic Goods Act 1989 (the Act) released on 23 September 2020, all sports supplements that are supplied in the dosage form of tablet, capsule, or pill other than goods containing glucose only, that are used, advertised, or presented for therapeutic use with claims relating to performance in sport, exercise, or recreational activity, will be fully regulated as therapeutic goods starting from 30 November 2023. The therapeutic use or likely to be taken for therapeutic use also includes: Gaining muscle Increasing metabolism Losing weight/fat Modifying hormone level Preparing for /recovering from the workout The 3 years transition period ending intends that the sports supplements are required to be included in the Australian Register of Therapeutic Goods (ARTG), while if the goods maintained labelled as medicines, instead of foods, the goods must be included in the ARTG either as listed medicines or registered medicines. The regulation also enforced the sports supplements that contain, or are represented to contain either of the following substances effectively from 30 November 2020: Substance included under the schedule to the current Poisons Standard Substance identified on the Prohibited List that is added as an ingredient to the supplements Relevant substance added as an ingredient Substance with equivalent pharmacological action to the substance mentioned above, including those characterized as an active principle, precursor, derivative, salt, ester, ether, or stereoisomer Sports supplements with no therapeutic use claims, contain appropriate food ingredients, and are packed in the traditional food form are excluded from the regulation, for instance, protein powders, nutrition bars, and energy drinks. Source: Therapeutic Goods Administration (TGA) Contact us at info@arqon.com for more information.

In accordance with Regulation No. 17/2023, Guidelines for Cosmetic Product Information Documents, the Indonesia National Agency of Food and Drug Control requires all Cosmetics manufacturers, importers, and/or any person or business entity to obtain a Dokumen Informasi Produk "Product Information Document" (DIP) for each cosmetic product before being notified and received notification number. The DIP is designed to keep track of the information on the safety, effectiveness, and quality of cosmetic products that must be documented by Cosmetic manufacturers, Cosmetic importers, and/or any other person or business entity who established the production contract that involved: Fulfillment of technical requirements for cosmetic ingredients related to safety, efficacy, and quality accompanied by scientific and empirical evidence Fulfillment of contamination requirements Monitoring results of any side effects of cosmetic products Fulfillment of marking requirements Fulfillment of claim conditions Cosmetic manufacturers, Cosmetic importers, and/or an individual/business entity that has acquired the Cosmetic notification number before the Body Regulation implementation, has a 6-month transition period to apply the DIP, starting from the enforcement of the Regulation Next, the audit inspection can be done in the facility of the Cosmetic manufacturers, Cosmetic importers, or any person or business entity that holds the manufacturing contract as the notification number holders, via offline or online virtual media communication. Cosmetic manufacturer, importer, or business entity that holds the manufacturing contract as the notification number holders, who fail to oblige the regulations, will be penalized through administrational penalty in terms of: Written warnings Temporary closure of online access for submitting notification requests for a maximum period of 1 year Temporary closure of online access for submitting import certificates for a maximum period of 1 year Prohibited to distribute Cosmetics for a temporary period, maximum for 1 year Withdrawal Cosmetics from distribution Temporary suspension of manufacturing and/or importing activities, maximum for 1 year Revocation of Notification Number The Cosmetic manufacturers, Cosmetic importers, and/or any person or business entity are responsible for updating the DIP on any related information changes. All the data shall be kept in the form electronic or non-electronic, for a minimum of 1 year, after the expiration date of the last batch of Cosmetics being manufactured or imported. Source: Badan Pengurusan Obat dan Makanan (BPOM)

As mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the FDA was designated new authorities for Cosmetics which are Facility Registration and Product Listing. This designation brought the FDA to draft guidance on cosmetic product facility registration and product listings. This finalized guidance is intended to assist stakeholders with the requirements and information needed for cosmetic facility registration and cosmetic product listing submission. The new authority duty for the FDA includes: Facility Registration: Required for all cosmetic manufacturers or processors to register their facilities with FDA, within 60 days of any changes, and apply registration renewal for every 2 years Product Listing: Responsible persons are compulsory to submit the list of marketed cosmetic product information and annual updates to the FDA **Responsible Person: Manufacturer, packer, or distributor of a cosmetic product, whose name stated on the label of the cosmetic product Previously in March 2023, MoCRA was mandated for the facility registration and product listing authorities upon the Constituent Update by FDA, which caused FDA to discontinue accepting submissions to the Voluntary Cosmetic Registration Program (VCRP). The draft guidance mentioned the intention of applying the FDA Establishment Identifier (FEI) as the required facility registration number for the registration process. This means that the facility owners are required to obtain an FEI number before the facility registration submission. The Responsible persons must obtain the FEI numbers from their cosmetic products’ facilities for the product listing submission. There are few exemptions given for small businesses from facility registration and product listing requirements except: Facilities that manufacture products that regularly come into contact with the mucus membrane of the eye under customary or usual conditions of use Facilities that manufacture products that are injected Facilities that manufacture products intended for internal use Facilities that manufacture products intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer are not part of such conditions of use Apart from that, the FDA is planning to implement the electronic registration and listing submission portal, which is intended to be available in October 2023. Hence, FDA motivates electronic submissions to facilitate efficiency and timeliness of data submission. FDA encourages members from the cosmetic industry to participate in the User Acceptance Testing (UAT) for potential evaluation of the new electronic portal. For the obligation of the FEI numbers, the stakeholders are advised to plan well on the registration and listing as the statutory deadline will be on 29 December 2023. Source: Food and Drug Administration (FDA) Contact us at info@arqon.com for more information.

United States (FDA) and Switzerland (Swissmedic) were mutually recognized as regulatory authorities for each country, effectively enforced from 27 July 2023, through the Mutual Recognition Agreement (MRA), signed in January 2023. The MRA was signed after the FDA and Swissmedic had carefully scrutinized each other’s monitoring procedures for manufacturing medicinal products and found them to be comparable. On-site inspection for medicinal manufacturing shall be done so the GMP certification acquired by the manufacturers can be made available to the partner authority. The GMP certification will be used to evaluate the manufacturer. The accreditation marks a significant turning point in Swissmedic's long-term partnership with the FDA. Besides, MRA also assures effective, safe, and high-quality medicinal products will be continuously available for patients from both USA and Switzerland. Source: Swissmedic Contact us at info@arqon.com for more information.