FDA Philippines issues draft guideline on categorization of borderline health products
The Food and Drug Administration Policy and Planning Service (FDA PPS) of the Philippines has issued draft guidelines for comments and input from industry stakeholders covering the categorization of borderline health products under the jurisdiction of the FDA. The FDA’s jurisdiction covers multiple product categories such as devices, cosmetics, drugs, food, and others. Some health products have been found to have characteristics that mean they fall under two or more categories or are borderline between different categories and are hence known as “borderline health products”. These borderline products can present difficulties in determining the appropriate categorization and therefore the appropriate regulatory framework which applies to the products they intend to market. As a result, this draft FDA Circular has been created to provide guidance in the categorization of borderline health products. The draft guidelines include:
- the considerations in determining product categorization; and
- the provision of an appropriate transitory period to allow the proper recategorization of borderline health products
- a preliminary list of borderline health products and their designated product categories – this can be found in Annex A. Examples of borderline health products include alcohol swabs, contact lenses, dentures, electric toothbrushes and eye drops.
Here is the summary of the draft FDA Circular:
- Market Authorization Holders (MAH) are responsible for:
- Determining the initial product category, by referring to Annex C
- inform the FDA of any changes that affect the product classification
- file for product classification / re-classification if it is unclear by referring to annex B – application procedure and requirements.
- Product classification should be undertaken according to the legal definitions of the product categories but also in conjunction with other recognized and adopted references, product claim(s), product presentation, product composition (formulation), the primary method through which the intended action is achieved, as well as the route of administration.
3. The FDA is responsible for:
- initiating a review of product classification when there are updates/ public health reasons.
- publishing and maintaining a list of borderline products with their identified classification (Annex A). The list shall be made available in the FDA website and regularly updated at least every year on the 15th of June and December.
- Products with valid authorizations requiring re-classification will be given a transitory period to comply with this guideline. The market authorizations of such products shall be recognized as valid for the remainder of their validity or extended for one (1) year from the effectivity of this Circular, whichever is later.
5. Where a product has been found to fall under two product classifications constituting a “combination” product, the market authorization applicant shall secure a market authorization from all the identified centers.
6. If during post-marketing surveillance when a product is found to be misrepresented under a different product classification, appropriate sanctions and penalties shall be levied.
The full draft of this draft FDA Circular can be accessed at https://www.fda.gov.ph/draft-for-comments-request-for-comments-and-inputs-on-the-draft-fda-circular-on-categorization-of-identified-borderline-health-products-under-the-jurisdiction-of-the-food-and-drug-administration-f/.
The deadline for the submission of comments and inputs is until 27 January 2022. Comments can be submitted by contacting your dedicated Andaman Medical Regulatory Affairs Specialist or directly through this google form link https://tinyurl.com/5n776hms.
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