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Cofepris implementing a new platform for processing the research and clinical trials digitally, named Digital Platform for Research and Clinical Trials (DIGIPRiS) with an objective as a strategic attraction for the medical industry. DIGIPRiS applies full transparency to all documents with no intermediary parties involved during the evaluation procedure. Besides, this digital platform is expected to shorten the evaluation period by up to 75% compared to the traditional method which also involves face-to-face meetings with Cofepris. All specialists who carry out clinical research on human beings were invited to utilize DIGIPRiS for new protocol requests and change submissions for the authorized protocols. The submissions via the digital platform can also be used for entry procedures, status review, and receipt of resolutions. The advancement procedure assists both the public and private sectors to obtain digital resolution in 6 steps and soon, there will be no more physical entry for research protocol requests on human beings. Technology evolution in developing research and expanding disease knowledge via DIGIPRiS helped to tighten the industry gap by the boosted responding time for the evaluation period and certain person-centered cases. This tactical strategy will attract bigger investments for the research sector in the medical industry. Source: Federal Commission for the Protection against Health Risks (COFEPRIS) Contact us at info@arqon.com for more information.

On 8 January 2024, the US Food and Drug Administration (FDA) rolled out a new authoring tool for cosmetic product facility registration and cosmetic product listing mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which is known as SPL Xforms or Structured Product Labeling (SPL). US FDA provides 3 options for submission of cosmetic product facility registrations and cosmetic product listings via electronic submission which are: Xforms Cosmetics Direct, can be submitted via the electronic submission portal SPL-formatted submissions through the Electronic Submissions Gateway (ESG) While FDA also provides manual methods by releasing Form FDA 5066 and Form FDA 5067 as submission tools in paper form for the cosmetic product facility registration and cosmetic product listing information to the FDA. However, FDA strongly suggests the submissions be made via electronic submissions for efficiency and timeliness of the data submission and management. Manufacturers, stakeholders, or responsible persons should be alerted of the delayed enforcement date which has been postponed to 1 July 2024. Hence, all responsible persons, manufacturers, or stakeholders have sufficient time to prepare for the facility registration and cosmetic product listing submission to the FDA. Source: US Food and Drug Administration (US FDA) Contact us at info@arqon.com for more information.

The National Single Window System Portal (NSWS) was launched on 1 January 2024 as a one-stop centre to facilitate investors and stakeholders in the applications of registration certificates and licenses to manufacture or import medical devices for various purposes, for instance, clinical investigations, tests evaluations, demonstrations, or training. Streamlining business processes was simplified for the stakeholders and investors, at the same time eliminating the need to navigate through multiple systems to apply, track, and obtain necessary information for business approvals. NSWS Portal will be working independently from the CDSCO online portal and SUGAM portal including the activities listed below under the Medical Devices Rules, effective from 1 January 2024: Application for grant of Certificate of Registration of a Notified Body Application for license to manufacture medical device for clinical investigations, tests, evaluation, examination, demonstration, or training (Form MD-12) Application for License to Import Medical Devices for Clinical Investigations, Tests, Evaluations, Demonstrations, or Training (Form MD-16) Hence, all stakeholders are required to submit applications related to the activities listed above through the NSWS portal and the existing system under CDSCO will be disabled effectively from 15 January 2024. Source: Central Drugs Standard Control Organization (CDSCO) Contact us at info@arqon.com for more information.

The National Pharmaceutical Regulatory Agency (NPRA) of Malaysia decided to enforce stringent measures against cosmetics manufacturers who have repetitive non-compliance records effective from 1 July 2024, in response to the rise in cosmetic manufacturers with “Unacceptable" GMP status during the GMP inspection since 2014. Besides, some cosmetic manufacturers consistently recorded repetitive non-compliance records with the “Unacceptable” status based on the previous GMP inspections. As part of the initiative to uphold the safety and quality control of the notified Cosmetics, NPRA rolled out a thorough review of the coordination of the regulatory actions to address the need for a consistent and effective approach towards the cosmetic manufacturers with repetitive GMP non-compliance records following Annex 1 Part 11, Guideline for Cosmetic Good Manufacturing Practice, August 2022 and Guidelines for Good Distribution Practice, Third Edition, 2018. Hence, the Committee Assessment Meeting for Premises Inspection and Study No. 9/2023 ruled out that NPRA will enforce stringent measures for cosmetics manufacturers with repetitive non-compliance in performance records, in which previous five (5) routine inspections or GMP investigation inspections will be referred to determine the regulatory actions that will be imposed as stated in the table below: Source: National Pharmaceutical Regulatory Agency (NPRA) Contact us at info@arqon.com for more information.

WHO Collaborating Centre (WHOCC) updated the ATC/DDD list of 5TH Levels on 12 December 2023 and the Danish Medicines Agency (DMA) released a reminder to all related marketing authorization holders (MAHs) of medicinal products that have been authorized under the national procedure, decentralized procedure, and mutual recognition procedure, to take note on the ATC codes changes. MAHs were advised to refer to the ATC codes for human medicinal products that will be listed in Medicine Prices on 22 January 2024. The same goes for veterinary medicinal products but this will be updated later in Medicine Prices. MAHs were required to apply for an update of the summary of product characteristics for the medicinal products if there are changes applied to the ATC code or text of the medicinal products that have been authorized under the national procedure, decentralized procedure, and mutual recognition procedure. MAHs may refer to the Guidelines for Variations Application for the medicinal products. Source: Danish Medicines Agency (DMA) Contact us at info@arqon.com for more information.

Starting 1 January 2024, the National Health Regulatory Authority (NHRA) of Bahrain will implement a new revision of exemption for medical devices importation under Circular 23 issued in 2020. The revision applied to applicants who have repetitive violation records by NHRA will require new medical device registration before importation. The authorized representatives should note that the exemption quota has been nullified. However, under special circumstances to ensure continuous market availability of essential medical devices, NHRA allows the importation of medical devices without registration by Circular 15 (2021). Hence, the authorized representatives are reminded to be updated with the latest regulations to avoid any market disruption and ensure to always comply with the national regulations to guarantee patients’ safety. Source: National Health Regulatory Authority (NHRA) Contact us at info@arqon.com for more information.

ANVISA published a new Collegiate Board Resolution, RDC 830/2023 on the 11th of December 2023, updating the rules for in-vitro diagnosis medical devices (IVDs) and will be rolled out effectively on 1 June 2024. The revision consists of risk classification consolidation, procedures for notification, registration, amendment, revalidation, cancellation of notification or registration, and labelling requirements for IVD medical devices. ANVISA intends to streamline the Brazilian regulatory pathway and align with international practices. Significant revisions were decided based on the risk of the IVD medical devices that may affect public health and users: Provide specific risk classification rules for IVD medical devices that do not use reagents; for products aimed at detecting transmissible agents or for immunological compatibility evaluation in cell administration procedures Provide classification rules for companion diagnoses of IVD medical devices and neonatal screening medical devices Any medical devices that are controlled without assigned values now have been classified as IVD medical devices and the responsible person must notify Anvisa within 1 year period of the new RDC enforcement The health risk differentiation for the medical devices aimed for blood gases or glucose either under the Point of Care Testing type (PoCT) or not has been demolished. Addition of permission to use instructions for use in non-printed format for controls and calibrators together with the previous requirements stated in Normative Instruction (IN) 04/2012 The responsible person should stay apprised of the enforcement date of the RDC 830/2023 and take action on any IVD medical devices classification to be modified since Anvisa provides 1 year period to file for the reclassification. Source: National Health Surveillance Agency (ANVISA) Contact us at info@arqon.com for more information.

The Drug Regulatory Authority of Pakistan (DRAP) decided to release the guidance of the finished drug product specifications to the pharmaceutical industry to ensure the standards are on par with the DRAP Act 2012 and The Drug (Specification) Rules 1978. 1. Drug Product Has Been Published in Pharmacopoeias Accordingly To Drug Specification Rules (1978) The firm is allowed to adopt the specifications from any pharmacopoeias as per the procedure mentioned within 1 year and shall apply for approval from the Registration Board DRAP. Till the approval from the Registration Board; The previous specifications approval by the Registration Board remains valid Specifications stated in S.No.2, Column 1 of rule No.2 of the Drugs (Specifications) Rules (1986) will be applied for any registration letter with no specifications mentioned but the drug products available in any pharmacopoeias Specifications of the innovator/manufacturer products that have been approved by any regulatory authority of reference countries will be accepted if neither the specification mentioned in the label nor the pharmacopoeias 2. Pharmacopoeia specifications of the relevant products that are subject to approval by the Registration Board, which are approved by the pharmacopoeia of the regulatory authorities from the reference countries that are approved by the Registration Board including FDA (USA), Health Canada (Canada), TGA (Australia), PMDA (Japan), UK MHRA (United Kingdom), BfArM (Germany), ANSM (France), Swissmedic (Switzerland), MED (Netherland), BASG (Austria), DKMA (Denmark), Läkemedelsverket (Sweden), FAMHP (Belgium), Icelandic Medicines Agency (Iceland), Fimea (Finland), HPRA (Ireland), NoMA (Norway), AEMPS (Spain), AIFA (Italy), and reference regulatory authorities of the EMA and WHO 3. For cases of drug products that are not yet available in pharmacopoeias as specified under Drug Specification Rules (1978) The firm may apply the innovator/manufacturer product specifications as approved by the regulatory authority of the reference countries but will remain valid only till the inclusion of the products in any of the pharmacopoeias as specified under Drug Specification Rules (1978). The firm shall apply the approval from the Registration Board of DRAP within 1 year period Generic applicants that prefer to manufacture with their specifications, must submit the data stated below for review and approval by the Registration Board of DRAP: Source: Drug Regulatory Authority of Pakistan (DRAP) Contact us at info@arqon.com for more information.

On 7th December 2023, the European Medicines Agency (EMA) updated the regulatory expectations and GMP certificates following the Covid-19 public health emergency current status. As informed globally by the World Health Organization (WHO), the status of Covid-19 public health emergency ceased in May 2023, hence the GMP/GDP Inspectors Working Group (GMDP IWG) decided to continue carrying out inspections on pharmaceutical factories and wholesalers that have been postponed due to the pandemic. Previously, the EMA, European Commission, and Heads of Medicines Agencies (HMA) released regulatory flexibility for medicines as a preventive initiative for regulatory and supply challenges due to the pandemic. To continue with the supervision, GMDP IWG decided to continue the validity of the GMP/GDP certificates until end of 2024. Inspectors will perform the risk-based supervision of sites, either on-site inspection or distant assessment. The inspections will be scrutinized based on risk priorities: sterile product manufacturers, biological product manufacturers, and wholesale distributors of pharmaceutical products. The inspectors may also be depending on the date of the last inspection. The authorities can take action on any serious non-compliance issue found during the inspection. The validity outcome of the GMP/GDP certificates, either can be issued continuously, have to withdraw from the current certificates, or remain restricted on the GMP/GDP certificates, should be addressed to the authorities that issued the certificates. Source: European Medicines Agency (EMA) Contact us at info@arqon.com for more information.

The Centre for Drug Evaluation (CDE) reviews its management of electronic submission and electronic common technical dossier (eCTD) structure. Also, it reveals Verification Standards for Electronic Application Materials categorized under the regulatory electronic document. This change implementation aims at quality and efficiency enhancement for producing electronic application materials for drug registration applications and to standardize electronic documentation management. This notice will be effectively implemented starting from 1 March 2024. 1. There are 3 regulatory documents involved with the updates: Technical Requirements for Electronic Discs of Application Materials (“Technical Requirements”) The updates define the numbering rules, acquire the application numbers, and add the application numbers for raw ingredients, pharmaceutical excipients, and packaging materials Compact disk requirements for electronic application materials (for storing data): use Standard 120 file-level CD-ROM with no options for re-writing, only write-once, may include additional software for data production (optional) Electronic Document Structure for Drug Registration Applications (“Document Structure”) Improvise the requirements for file and folder expansion Review each application item and their folder’s structure and path Adding new “clinical database folder” and electronic files for pharmaceutical excipients and pharmaceutical packaging materials Verification Standards for Electronic Application Materials (“Verification Standards”) Divided into 3 parts: basic information, files/folders, and integrity The electronic verification will not pass after verifying the electronic declaration materials (CD submitted by the applicants) with several errors If the electronic declaration materials pass the verification, the CD will go through the subsequent process. Applicants may check the verification progress via the “Applicant Window” on the CDE website 2. Compact Disk Sorting Applicants are required to submit one completed compact disk (including the clinical trial database, if required) for CDE inspection For applications with the verification exception (drug clinical trial applications, overseas-produced drug re-registration applications, supplemental applications that directly seek administrative approval), applicants are required to submit one completed compact disk (including clinical database, if required) for the Centre for Food and Drug Administration (CFDA) inspection Any first-time drug registration application submissions after 1 March 2024, only supplementary information is required to be submitted CDE informs that applicants can voluntarily choose to use the electronic declaration data production software with built-in features of signing and verification that help to generate declaration materials equivalent to the requirements needed. Source: Centre of Drug Evaluation (CDE) Contact us at info@arqon.com for more information.

Due to the scheduled maintenance system, the Ministry of Health (MOH) announced the temporary closure of the medical device licensing system, PKRT system, and online certification system. The closure is expected to affect 3 systems, Application for Medical Devices Distribution Permit (IDAK), Application for Medical Devices Marketing Authorization, and Online PKRT, and Application of Online Certification. Manufacturers, responsible persons, or any party engaged in the documentation process should take note of the important dates outlined below. A.    Application for Medical Devices Distribution Permit (IDAK) (** Company license to distribute medical devices) All matters concerning the submission of the new application registration documents, extensions, amendments, or extensions with amendments will be under temporary closure starting from 18 December 2023 – 5 January 2024. IDAK applications under the evaluation process will continue to be processed. IDAK applications under the status of Registrant – Additional Data, will not be processed during the closure and the estimated time will be frozen. IDAK applications with approved billing codes/payment orders (SPB) must submit the payment proof before 29 December 2023. B.  Application for Medical Devices Marketing Authorization and Online PKRT (** Product license to import and sell to the market) All matters concerning submitting the new registration application for marketing authorization, extensions, amendments, or extensions with amendments will be temporarily closed from 18 December 2023 – 5 January 2024. Applications under the evaluation process, documents with additional data, and NIE document reviews will continue to be processed. All applications with approved billing codes/payment orders (SPB) for 2023 are required to submit the payment proof before 29 December 2023. Applications for distribution permits that have entered the evaluation process will continue to be processed as appropriate. If there are additional data documents and review of NIE documents, they can still be processed as appropriate. Any marketing authorization that will expire during the temporary closure period is required to request extensions before 15 December 2023, or a new application should be submitted after the expiry. C. Application for Online Certificates Submission of online certificate applications will be temporarily closed from 20 December 2023 – 29 December 2023. All applications that are undergoing the evaluation process will continue to be processed. Application with the status Registrant – Additional Data will be closed temporarily and the estimation time will be frozen. All application submissions in 2023 with approved billing codes/payment orders (SPB), are required to settle the payment, check the payment status, and submit the payment proof before 29 December 2023. Source: Ministry of Health of the Republic of Indonesia (MoH) Contact us at info@arqon.com for more information.

The Medical Device Division (MDD) issued a guidance, “Guidance Notes on Changes for Listed Medical Device (GN-10)” to guide the Local Representative Person (LRP) in categorizing, managing, and reporting the changes related to the listed medical devices under MDACS. LRP should start complying with the new requirements from 1 January 2024. Changes intended in the guidance are divided into 2 types: Major Change and Minor Change. Major Change refers to any changes that would affect the safety, quality, and performance (SQP) of the medical device, which also LRP should take note of any possibility of: The result in risks to the patient that were not previously identified Probability increments of the existing hazards that may occur Alteration to the presentation of existing or new risks to the user (may involve labeling changes or new indications for use) The listing will be invalid if the medical device undergoes any changes without notifying the MDD. For any Major Change without notifying the MDD, the medical device will be removed from the listed medical devices under MDACS and LRP should cease all medical device supply. Reporting Changes Supply of Changed Medical Devices LRP should be responsible for ensuring the proposed schedule must be included in the Change Application, for supplying both the original and changed version of the medical device concurrently. The original version is allowed to be supplied only if still able to comply with the Essential Principles of Safety and Performance of Medical Devices by MDACS. Otherwise, 24 weeks is given as the transition period to the changed version, or period stated by the MDD. Application Procedures LRP should submit any changes for the listed medical device by using the Change Application form to the MDD, via email, by hand, or by mail MDD will acknowledge the submission upon receipt and LRP may enquire to MDD within 2 weeks for submission confirmation It is upon the discretion of MDD to request for new listing submission or proceed with the change application, depending on the circumstances and information submitted MDD would not accept multiple submissions of the same device while the previous submission is under evaluation review. LRP should withdraw the previous Change Application that is under evaluation and submit a new Change Application including all changes and supporting documents (for unavoidable cases) LRP should not proceed with any changes if the application is rejected, otherwise, the listing status will be invalid LRP should request for replacement of the Listing Certificate by returning the original copy to the MDD (for necessary issuance) LRP may refer to the guidance here for detailed flowcharts of situations to determine the major or minor changes needed for the listed medical devices Source: Medical Device Division (MDD) Contact us at info@arqon.com for more information.