Regulatory Focus™ > News Articles > 2021 > 8 > Asia-Pacific Roundup: India okays a handful of FDCs as long saga continues

Asia-Pacific Roundup: India okays a handful of FDCs as long saga continues

Posted 31 August 2021 | By Nick Paul Taylor 

Asia-Pacific Roundup: India okays a handful of FDCs as long saga continues

India’s Central Drugs Standard Control Organization (CDSCO) has deemed 31 fixed-dose combinations (FDCs) as rational some 14 years after India ordered the withdrawal of 294 FDCs only for manufacturers to mount a legal challenge.
 
Most of the FDCs deemed to be rational in the past week are part of the original 294 products targeted by the Indian authorities. The 31 products were assessed by India’s Drugs Technical Advisory Board (DTAB) and the Kokate Committee set up to review FDCs earlier this year following a referral from a high court.
 
Companies that have state licenses for their now rational FDCs — licences that enabled products to come to market without a review of their rationality by the national regulator — and lack no objection certificates from the Drugs Controller General of India need to file for CDSCO approval within six months. The companies need to file the CT-21 form that covers requests to manufacture new drug formulations.
 
CDSCO issued news of the rationality of the 31 FDCs on the day it released two related updates. Regarding the rationality of three other FDCs that were discussed by DTAB earlier this year, CDSCO has concluded they are rational, provided manufacturers comply with certain conditions such as restricted indications and the completion of in vitro assessments of efficacy.
 
The third update provided by CDSCO covers the need for further evidence about 19 FDCs. CDSCO is asking manufacturers of the products to run Phase IV clinical trials or post-marketing to generate data to support continued. 
 
CDSCO Notice, Cefixime Notice, More
 
TGA: Roche’s Actemra is stable after expiry date
 
Australia’s Therapeutic Goods Administration (TGA) has found Roche’s Actemra remains stable for six months after the labeled expiration date – a move that could allow more patients to access the IL-6 inhibitor amid a shortage created by its use in COVID-19.
 
In recent months, the World Health Organization and the US Food and Drug Administration have issued positive opinions about the use of Actemra in certain patients with severe or critical COVID-19, driving up demand for the product. TGA expects the shortage of intravenous Actemra to last until January.
 
Some Actemra vials in Australia are close to expiration, prompting TGA officials to reach out to Roche about the product’s stability beyond its stated 30-month shelf life. Roche supplied evidence that the drug remains stable at 2°C to 8°C for 36 months. No evidence is available after 36 months.
 
TGA shared the stability data without telling healthcare professionals what to do. “Given the additional stability information provided above, clinicians should consider the risks and benefits of treating patients when only expired tocilizumab vials are available,” the agency wrote in its update. TGA will not be changing the approved shelf-life included in the product information
 
The advice only applies to Actemra vials, not the pre-filled syringe and autoinjector formulations sold by Roche. TGA has previously sought to improve access to those Actemra dosage forms by allowing pharmacists to substitute them.
 
TGA Notice
 
Singapore revises Drug Master File process to avoid unnecessary screening queries
 
Singapore’s Health Sciences Authority (HSA) has changed the evidence requirements for Drug Master File (DMF) submissions to “avoid any unnecessary screening queries and stop-clock for clarifying the status and completeness.”
 
As of 1 September, HSA will accept the acknowledgement emails it sends upon receipt of the Letter of Access from the DMF holder as evidence that all the required documents have been submitted. HSA made the change to “facilitate timely screening” of applications once they are submitted to its online Pharmaceutical Regulatory Information System, also known as PRISM.
 
HSA wants applicants to include the acknowledgement email in all applications supported by a DMF. The agency updated its guidance in conjunction with the change. The email is now named alongside a copy of the Letter of Access and the open part of the DMF in PDF format on the list of documents applicants need to submit to HSA.
 
The agency disclosed the new requirements alongside news of the introduction of an online self-guided tool for post-approval minor variation applications. The tool is designed to enable the industry to “get quick answers on the application type, variation category and documentary requirements for such variations,” as well as to help companies file high quality submissions.
 
HSA framed the introduction of the tool as part of its effort to improve understanding of regulatory requirements in Singapore and make it easier to access the information needed to create high quality submissions. The agency envisages companies using the tool rather than emailing requests for information and clarification. 
 
HSA Notice, DMF Guidance
 
TGA finds pediatric medicinal cannabis products comply with active ingredient rules
 
All eight samples of pediatric medicinal cannabis products tested by TGA have met requirements for the content of the active ingredient. Levels of cannabidiol (CBD) in the products ranged from 94% to 108% of the stated content.
 
Australia’s standard for pediatric medicinal cannabis permits products to contain between 90% and 110% of the stated content of the active ingredient. To assess if products supplied under the Special Access Scheme comply with that requirement, TGA requested samples of nine medicinal cannabis products. One of the companies did not send a sample as the product was discontinued.
 
The eight tested products were supposed to contain between 50 mg and 240 mg of CBD per mL. TGA found all eight products were within the regulated range, with MGC Pharmaceuticals, at 93.9%, and Little Green Pharma, at 107.7%, being the closest to the lower and upper limits.
 
TGA Notice
 
Pakistan shares guides to online license applications from CROs and study centers
 
The Drug Regulatory Authority of Pakistan (DRAP) has published a guide to how contract research organizations (CROs) and other stakeholders can use its online system to apply for licenses.
 
DRAP’s guide walks through the process for completing online forms to apply for licenses to operate as a CRO, clinical trial site, bioanalytical laboratory and bioequivalence study center. The guide also covers the process for applying to run clinical trials and bioequivalence and bioavailability studies.
 
The Pakistani regulator released the guide alongside a document detailing the process for filing to register new establishments, renew medical devices and medicated cosmetics licenses, and submit data in relation to existing licenses.
 
DRAP Guide, More
 
Other News:
 
TGA has updated its question-and-answer document on the conditions for the supply of COVID-19 rapid antigen tests. The updated document features a new question about buying the tests. TGA has linked to a list of all rapid antigen tests approved in Australia and asked interested parties to contact the sponsors for details of the cost and buying process for the products. TGA Q&A
 
TGA has published details of its testing of listed medicines for a neurotoxin and cardiotoxin. The levels of  Aconitum alkaloids were below the limits of detection in 18 of the 19 tested products. The product that tested positive was removed from the market last year. TGA Notice

 

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