Compared with two previous drafts, the newly released amendment introduces stricter guidelines for initial, renewal and variation applications for the LTO, detailing the circumstances under which the LTO may be cancelled, and strengthens the requirements for the Qualified Person.
On June 5, 2023, Philippines Food and Drug Administration (FDA) released a new draft of Updated Guidelines on the Application for License to Operate of Health Product Establishments with the Food and Drug Administration (the Updated Guidelines). Any comments can be sent to pps@fda.gov.ph, with a copy to pfpid@fda.gov.ph, no later than June 30, 2023.1
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Under the current regulatory framework, cosmetics registrants and notifiers can continue to submit a simplified version of the safety assessment report during the registration or notification process until May 1, 2025. Following this deadline, a full version of the safety assessment will be mandated. To facilitate a smooth transition, China is planning to release a set of technical guidelines.
The current cosmetic technical standard STSC 2015 specifies the cosmetics' general safety standards, prohibited/restricted/permitted ingredients and testing methods. It is revised aperiodically in response to changing trade practices in the industry. China is planning to issue a new version of STSC.
