Asia-Pacific Roundup: Philippine FDA consults on changes to drug product and API rules
The Philippine Food and Drug Administration (FDA) is holding a consultation into proposed changes to its rules and regulations on the authorization of pharmaceutical products and active pharmaceutical ingredients (APIs) for human use.FDA established revised rules on the registration of pharmaceutical products through the publication of an administrative order in 1989. The agency framed the proposed update to the rules as a response to “the fast changing technologies and regulatory landscape in pharmaceutical regulations” and outlined how those changes and other factors are shaping its policy.
“There is a need to develop responsive policy guidelines for the authorization of drugs by providing scientific evidence on the quality, safety and efficacy of the products being applied,” FDA said. “Also, institutionalizing regulatory reliance is necessary to avoid redundancy in regulation particularly products that are already authorized in other countries that passed the stringent regulatory review process.”
The new administrative order is intended to provide guidelines on the identification of registrable pharmaceutical products and APIs, the types of registration applications for pharmaceutical product and API authorization, regulatory review implemented by FDA on the applications and applicable evaluation pathways, and regulatory decisions on the applications.
FDA listed three key changes to its existing advice on those topics. In the draft, the agency has adopted terminology that is harmonized with its other documents, specifically the terms pharmaceutical product and active pharmaceutical ingredient. FDA defines both terms in the draft order.
The agency also said it has “updated provisions under definition of terms, general conditions and types of applications covering the identical pharmaceutical product applications (IPPA) to be established.” FDA said identical pharmaceutical product refers to “a pharmaceutical product that is identical to a principal pharmaceutical product in terms of the manufacturer of the finished product and the pharmaceutical formulation.”
There are two types of IPPA approval, independent, IPPA-1, and principle-dependent, IPPA-2. Products approved under IPPA-1 have independent marketing authorization as generic pharmaceutical products. “Post-approval changes on the principal product applied through IPPA-1 shall be treated as post-market surveillance information on the independent pharmaceutical products or vice versa,” FDA said.
Products approved under IPPA-2 are dependent on the authorization of the principal product, meaning “post-approval changes to the principal pharmaceutical product must be applied by the authorization holder of the identical pharmaceutical product to FDA to maintain its validity.”
The third key change identified by FDA are general provisions to allow for the bundling of applications for post-approval changes. When a post-approval change affects multiple products or a principal product and its dependent products, companies can bundle multiple post-approval change applications into one submission.
FDA is accepting feedback on the draft until 30 May.
FDA Notice
Malaysia’s MDA upgrades Medical Device Centralized Reporting System
Malaysia’s Medical Device Authority (MDA) has announced upgrades to its Medical Device Centralized Reporting System (MeDCReSt). The agency was scheduled to upgrade the system from 17 to 19 May.
MDA published a notice last week to warn the medtech industry that its reporting system would be offline on Friday, Saturday and Sunday. The agency explained the need for the update and how it will improve the system.
“This upgrade is required to enhance the efficiency, security and functionality of the system, ensuring a more seamless experience for all users,” MDA said. “With these upgrades, MeDCReSt will provide a better platform for reporting any post market issues related to medical devices, streamlining processes, and ultimately contributing to the advancement of healthcare delivery in our nation.”
The system was due to come back online on 20 May. As of early afternoon, Malaysian time on 20 May, the MeDCReSt login screen and public view listing were available. Pages that display guidance and frequently asked questions were unavailable because they were “under maintenance.”
MDA Notice
Philippine FDA extends transition to PIC/S GMP Guide until January 2025
The Philippine FDA has extended the transition to the current PIC/S Guide to good manufacturing practice (GMP) for medicinal products.
Under FDA rules on the adoption and implementation of PIC/S standards, the Philippines automatically adopts the latest GMP guide and provides a one-year transition. PIC/S brought version PE 009-14 into force in July 2018. FDA wrote to the industry in February 2023 to say it was imposing “strict compliance” with PE 009-14.
The agency’s 2023 notice also said companies are expected to “make the necessary preparation and transition towards the adoption of the PIC/S Guide Version No. PE 009-16.” PIC/S brought PE 009-16 into force in February 2022, establishing a new annex that could “better convey expectations associated with product release and further international harmonization efforts.”
Last week, FDA said it has extended “conformity of all involved stakeholders to PE 009-14 until 15 January 2025.” The timeline is “relative to the transitory provision stipulated” in the original administrative order, FDA said.
FDA Notice
DRAP pins Pakistan’s eye drop shortage on shift from Allergan to AbbVie
The Drug Regulatory Authority of Pakistan (DRAP) has attributed a shortage of certain brands of eye drops to “the change of ownership globally from Allergan to AbbVie.”
AbbVie bought Allergan for $63 billion in 2020 but has continued to use the brand for products such as the medical aesthetic treatment Botox and eye care product Restasis. After receiving reports that some eye drop brands are in short supply, DRAP surveyed the market in Pakistan. The survey showed that the move from Allergan to AbbVie has affected supply of some products, but alternatives are available.
DRAP said Alphagan, Combigan and Lumigan eye drops are in short supply because of AbbVie’s takeover of Allergan. The agency listed at least one alternative brand for each of the affected Allergan products. DRAP also reported the shortage of OBS Pakistan’s Cosopt. In that case, 30,000 packs are in transit and two alternative brands are available.
DRAP Notice
TGA allows pharmacists to substitute Orencia to ease Australian shortage
Australia’s Therapeutic Goods Administration (TGA) has made a serious scarcity substitution instrument (SSSI) to help manage a shortage of Bristol Myers Squibb’s autoimmune disease drug Orencia (abatacept).
The shortage affects 125 mg/mL formulations of Orencia for subcutaneous administration. Manufacturing delays are affecting the availability of a 125 mg/mL autoinjector. The 125 mg/mL prefilled syringe is in shortage because of an expected increase in consumer demand. TGA said the shortage has started earlier than expected and most patients now need to switch to other medicines.
TGA shared details of the SSSI on the day it provided an update on the timing of the shortage. Through the SSSI, pharmacists have gained the power to dispense 125 mg of abatacept in a prefilled syringe to fill a prescription for 125 mg of abatacept in an autoinjector, and vice versa.
The SSSI is scheduled to stay in place until the end of October. TGA expects the shortage of the autoinjector and prefilled syringe formulations to continue until the end of August and end of September, respectively.
TGA Notice
Other News:
The World Health Organization (WHO) has prequalified Takeda’s live-attenuated dengue vaccine TAK-003. The prequalification of TAK-003 makes a second dengue vaccine eligible for procurement by UN agencies in countries in Asia and other parts of the world affected by the virus. WHO Notice
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