Asia-Pacific Roundup: Philippine FDA seeks feedback on streamlining regulatory filing process

The Philippine Food and Drug Administration (FDA) is running a consultation about planned changes to its application system and documentary requirements for pre-license filings.
 
FDA has two goals for the changes: to further reengineer and streamline its processes and automate its system for initial, renewal and variation application for license to operate (LTO) through the eServices Portal System; and to update the list of documentary requirements for pre-license application and the technical requirements that shall be presented during inspections of regulated establishments.
 
The objectives reflect the regulatory challenges that the agency identified as it began implementing the revised guidelines on unified licensing requirements and internal processes. To address the challenges, FDA has proposed changes to the guidelines it published in 2020.
 
FDA has changed the requirements for initial LTO applications. In addition to the four original requirements, the agency is asking applicants to provide a self -assessment checklist and certificate of compliance with technical requirements. Manufacturers also need to provide a site master file, risk management plan and floor plan.
 
The agency has also revised the process for filing applications. While the main steps are unchanged, FDA has added text to clarify that all transactions “shall be communicated to the applicants using the registered e-mail address provided during the initial application.” The applicants need to ensure that the email address “is within the scope and access of the Authorized Person/s and/or Qualified Personnel of the establishment.” FDA also added text about how to obtain and display the LTO.
 
Officials are also seeking feedback on changes to the guidance on inspections. FDA has expanded on the inspection process in the revised draft, explaining that it has the authority to enter establishments “during operating hours to conduct routine or spot check inspections” and may work in collaboration with local government units or other agencies. The agency is softening its approach on “virtual offices,” allowing companies to have them if they have a physical site where the FDA-licensed activity takes place.
 
Changes to the general section of the guidelines include a tweak to the rules on Qualified Persons, which now state establishments need at least one who cannot be connected to other FDA-regulated sites, and the clarification that facilities must comply with applicable standards such as good manufacturing practices.
 
FDA is seeking feedback until 14 October.
 
Draft Guidelines
 
India grants 6-month reprieve to medical devices awaiting MDR 2017 licensing decisions
 
India’s Central Drugs Standard Control Organization (CDSCO) has given importers and manufacturers of some medical devices more time to secure the licenses needed to operate under the new regulatory framework.
 
On 1 October, CDSCO implemented the new medical device licensing regime for Class A and B products. However, ahead of the implementation date, the agency received requests from industry associations and stakeholders to delay the deadline to avoid disruption to the supply of products. If enforced, the rule would have required manufacturers and importers of Class A and B devices to have product licenses.
 
In response to the requests, CDSCO has granted a grace period to device companies that submitted an application to a state or central licensing authority by 30 September. Companies with pending licenses under the Medical Device Rules (MDR), 2017 can continue to manufacture or import their Class A and B products for up to six months or until they receive an application decision, whichever happens first.
 
Giving companies more time mitigates the risk that the supply of Class A and B products, groups that cover low to low moderate risk medical devices such as surgical dressings and tracheal tubes, will be disrupted by the implementation of the licensing requirements.
 
CDSCO Notice
 
Pakistan adopts virtual model based on FDA guidance for overseas GMP facility inspections
 
The Drug Regulatory Authority of Pakistan (DRAP) has adopted a risk-based virtual inspection program for assessing the compliance of overseas production facilities with good manufacturing practices (GMPs).
 
DRAP will assess risk based on the complexity of each product. Manufacturers selected for remote virtual assessments must have adequate communication tools for desktop review of information and for video assessments. DRAP lists videoscopes, inspection cameras, borescopes and fiberscopes among the technologies that may be needed, depending on the operations at the manufacturing site.
 
If a site cannot be assessed remotely without posing a potential serious threat to public health, DRAP will consider performing a hybrid or on-site inspection.
 
After reviewing the virtual inspection methods adopted by other regulatory agencies, DRAP advised the industry to refer to the US Food and Drug Administration’s guidance on inspecting facilities during the COVID-19 pandemic for advice on the conduct of remote assessments.
 
DRAP Notice
 
TGA fines medicinal cannabis companies AU$1M over unlawful advertising allegations
 
Australia’s Therapeutic Goods Administration (TGA) has hit three medicinal cannabis companies with a combined fine of almost AU1 million ($650,000) over alleged unlawful advertising on their websites and social media.
 
The three companies, MGC Pharmaceuticals, Cannatrek and Little Green Pharma, each received more than 20 infringement notices that added up to fines of more than AU$ 300,000 for each business. TGA issued some of the infringement notices in relation to the alleged promotion of prescription-only medicinal cannabis products, including in certain cases their own named products, that are unapproved.
 
According to TGA, the companies promoted products that are not entered on the Australian Register of Therapeutic Goods, including in adverts that featured unapproved references to the treatment of serious diseases or conditions such as cancer and epilepsy. Some adverts allegedly “suggested or implied that particular medicinal cannabis products were recommended or approved by a government authority.”
 
Australia has legal pathways through which medical practitioners can prescribe medicinal cannabis but, as unapproved prescription-only medicines, the products covered by the infringement notices cannot be advertised to consumers. The ban reflects fears that direct-to-consumer promotion of prescription-only medicines will underpin the doctor-patient relationship and create “inappropriate demand” for drugs.
 
TGA Notice
 
Philippine FDA adopts abridged process for medical devices approved in ASEAN countries
 
The Philippine FDA has adopted an abridged pathway for processing applications for the registration of medical devices that are already approved in another Association of Southeast Asian Nations (ASEAN) country.
 
In recent years, FDA has worked to make better use of the outputs of other regulatory agencies, including its counterparts in other countries in the ASEAN political and economic union. The ASEAN Medical Device Directive Common Submission Dossier Template (CSDT) has supported the reliance agenda by aligning registration requirements.
 
Under the abridged process, FDA will offer a streamlined review to medical devices approved under the AMDD-CSDT requirements in another ASEAN member country. In vitro diagnostics and refurbished medical devices are ineligible for the abridged process.
 
Manufacturers of eligible medical devices can receive registration in the Philippines by submitting a form that states the product details submitted to FDA are identical to those used in the reference approval. If there is an unauthorized change, FDA will automatically suspend the license to operate and certificate of medical device registration.
 
FDA Notice
 
Other News:
 
TGA has granted provisional determination to a version of Moderna’s bivalent COVID-19 booster vaccine that is designed to protect against the original SARS-CoV-2 virus and the omicron BA.4/BA.5 subvariants. TGA Notice