Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 12 April 2016 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
DCGI Seeks Feedback on Proposal to Phase Out Gelatin-Based Capsules
The Drug Controller General of India (DCGI) is seeking feedback on a proposal to replace gelatin with cellulose in drug capsules. If enforced, the transition would represent a major change for the capsule manufacturing industry, the output of which is currently dominated by gelatin-based products.
DCGI is reportedly considering implementing the change at the behest of an advisory panel. Exactly why the panel thinks the change is worth considering is unclear, but its interest in the topic has led to DCGI putting out a call for feedback. DCGI has given the industry, consumers and other interested parties six weeks to comment on the proposal, a timeline that The Times of India reports could result in the regulator making a decision by the end of May.
Early comments to the media suggest the proposal will receive a tough reception. “There will be chaos in the pharma industry,” Ajit Singh, managing director of capsule producer ACG Worldwide, told The Economic Times. Singh said cellulose capsules are more expensive than gelatin versions, and as such the switch may drive up the cost of drugs, although there is some disagreement among experts about the likely financial impact of the proposal.
Other critics of the proposal have questioned the feasibility of switching all capsules to cellulose. The concern is underpinned by doubts about whether cellulose is suitable for use in all formulations. This issue also affects gelatin-based capsules, though. The incompatibility of gelatin and drug substances contributed to the Bureau of Indian Standards (BIS) drafting a technical document covering the use of hydroxypropyl methyl cellulose last year.
The BIS document, the creation of which is part of a chain of events leading to the DCGI proposal, also cited the regulatory burden of ensuring gelatin is free from bovine spongiform encephalopathy, a condition commonly known as mad cow disease, as a factor driving interest in cellulose. Religious, cultural and personal issues are also a consideration, particularly in India where around one-third of people are vegetarian and religion prohibits others from consuming cow- and pig-derived products.
All of these issues are longstanding, but the campaign to switch to cellulose has been given impetus by more recent developments. “There has been shortage in supply of gelatin following ban on cow slaughter in some states,” Dr. Avinash Srivastava, a Delhi-based veterinary expert, told Mail Today. The shortage is one factor that could contribute to people looking favorably on the proposal, variants of which have reportedly been discussed in the past without coming into force.
DCGI Letter, The Economic Times, Mail Today, The Times of India, In-Pharmatechnologist
CFDA Sets out Plan for Enforcing Medical Device Clinical Trial Standards
The China Food and Drug Administration (CFDA) has detailed how it expects local regulatory officials to enforce the incoming requirements on clinical trials of medical devices. Officials are expected to step up the routine supervision and inspection of clinical trials to ensure standards are being met.
CFDA unveiled its good clinical practices (GCP) for medical device trials late last month alongside an explainer to help organizations interpret the document. Now, CFDA has released a related text aimed at regional officials, the regulatory foot soldiers who will shoulder responsibility for ensuring medical device clinical trials comply with the new standards. The document breaks the tasks facing regional officials into three categories.
From the perspective of organizations running clinical trials in China, the third category is perhaps the most significant. CFDA wants officials to take responsibility for overseeing studies in their region, specifically by strengthening the routine inspection of clinical trial sites. Officials are expected to use the inspections to enforce the new norms proposed in CFDA’s GCPs, the details and propagation of which are the focus of the regulator’s two other demands on regional offices.
CFDA expects local officials to build up a full understanding of the standards and, in doing so, equip themselves to enforce the GCPs during inspections. In parallel to these enforcement activities, CFDA wants local officials to work to spread understanding of the GCP standards among the organizations they regulate. Specifically, officials are expected to publicize the standards and provide personnel training, initiatives that may mean more clinical trials are compliant with the GCPs when inspected.
CFDA Statement (Chinese)
TGA Mulls Allowing OTC Sales of Emergency Contraceptive
The Therapeutic Goods Administration (TGA) of Australia is proposing to reclassify ulipristal acetate as an over-the-counter product when used as an emergency post-coital contraceptive. Currently, the product is classed as a Schedule 4 entry, meaning it is only available by prescription.
If emergency contraceptive use of ulipristal acetate is reclassified under Schedule 3, people would be able to obtain it from pharmacists without a prescription. Australia first reclassified an emergency contraceptive as a Schedule 3 product in 2004, but ulipristal acetate was denied this status when it was assessed by TGA last year. In its assessment, TGA said classing ulipristal acetate, which is sold as ellaOne, as a Schedule 4 product would minimize the risk of the drug being used off-label.
The product was initially classed as a prescription drug for the same reason in the United Kingdom, where concerns about the potential for it to be used to induce abortions were raised in parliament. Subsequently, ellaOne won approval in the European Union as a nonprescription product, leading to its reclassification in the UK last year. The decision followed an analysis of post-marketing data on the drug.
“Clinical and post-marketing experience demonstrate that [ulipristal acetate] is neither perceived nor utilized as an abortifacient. There have been no reports of attempts to use it with such intent,” the marketing authorization holder told European regulators. TGA referred to European evidence of the limited risk of off-label use in its original analysis, but nonetheless chose a Schedule 4 classification. Now, the regulator is seeking feedback on a proposal to change its original decision.
Australia Establishes Pediatric Influenza Vaccine Options for 2016
Australia’s TGA has released a list of influenza vaccines that are suitable for children of various ages. The list is intended to ensure children below certain ages only receive particular vaccines, thus cutting the risk of adverse events.
BGP Products and GlaxoSmithKline’s trivalent vaccines Influvac and Fluarix are both classed as being suitable for use in children aged six months and older, as is Sanofi-Pasteur’s quadrivalent product FluQuadri Junior. Sanofi has designed FluQuadri Junior specifically for the infant population. While the standard version is sold in 0.5 mL prefilled syringes containing 60 micrograms of haemagglutinin, the quantities are halved in the Junior variant.
The range of quadrivalent options broadens once a child turns three years of age. As well as the adult version of Sanofi’s FluQuadri, children aged three years and older are eligible to receive Fluarix Tetra, a quadrivalent vaccine manufactured by GSK. TGA has also included one vaccine that is only suitable for children aged five years and older. The vaccine, Seqirus’ Fluvax, is associated with the risk of fever and febrile convulsions in young children.
Such adverse events have occurred in children aged older than five years. As such, TGA is advising that careful consideration be given before the vaccine is given to anyone aged under nine years old. The message is conveyed in a black box warning on the product.
Tags: DCGI, Asia Regulatory Roundup, device clinical trials, flu vaccine in Australia