Asia Regulatory Roundup: New Zealand Pushes Ahead With Paracetamol Reclassification Despite Objections

Regulatory NewsRegulatory News | 11 December 2018 |  By 

New Zealand Pushes Ahead With Paracetamol Reclassification Despite Objections
Regulators in New Zealand have reaffirmed their intention to reclassify modified-release paracetamol as a restricted medicine. Officials proposed strengthening the restrictions on the medicine earlier this year and stuck with their decision despite respondents objecting to the reclassification ruling and how it was reached.
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) began looking into the classification of modified-release paracetamol after European regulators suspended the products this time last year. The European suspension was underpinned by concerns that, while modified-release paracetamol can be used safely, it can be impossible to know which version of the drug someone has used to overdose. As the version dictates treatment, this makes it hard to counter overdoses.
The European Medicines Agency (EMA) felt the risks posed by the overdose uncertainty outweighed the benefits, leading the European Commission to issue a legally binding decision in February. However, some national regulators have diverged from EMA. In May, Denmark opted to keep modified-release paracetamol on the market.
A parallel debate has gone on in Australia and New Zealand. In September, Australia’s Therapeutic Goods Administration proposed reclassifying modified-release paracetamol so that patients need to talk to a pharmacist before making a purchase. Medsafe held a consultation on its plans to reclassify modified-release paracetamol as a restricted, not pharmacy-only, medicine earlier in the year.
Medsafe received seven responses to its consultation. Four of the responses advocated for the drugs to remain as pharmacy-only products. Medsafe deemed one of the responses to be a valid objection, as it noted that new safety information is available. The response accused the committee of failing to properly assess all the risk-benefit issues.
The Medicines Classification Committee (MCC) considered the objections at a recent meeting. MCC placed little value on the label changes submitted by GlaxoSmithKline, noting that other companies make modified-release paracetamol and that the revisions cover the situation in Denmark, not new safety data.
MCC remained concerned that, while overdoses on modified-release paracetamol are relatively rare, the formulations are involved in a disproportionately high number of accidental overdoses. Involving pharmacists in the purchasing process may reduce the number of accidental overdoses.
Ultimately, MCC deemed the restricted status to be most appropriate “because it maintains [over-the-counter] access while ensuring that consumers receive adequate information to ensure the medicine is taken correctly.” The change may, as MCC accepts, reduce access to the modified-release formulation. However, the committee was satisfied alternative medicines were available.
Meeting Minutes
India’s CDSCO Seeks Feedback From Users of Online Drug, Medical Device Portals
India’s Central Drugs Standard Control Organization (CDSCO) is seeking feedback on its Sugam online portal. The consultation is designed to ascertain how users feel about Sugam now that parts of the online regulatory portal have been operational for more than two years.
To gather information, CDSCO published nearly identical feedback forms aimed at drug and medical device companies. The forms ask users to grade eight aspects of the portal on a scale ranging from one, strongly disagree, to five, strongly agree. CDSCO will use the responses to give an overall score out of 40.
The eight topics CDSCO wants users to grade cover whether Sugam is user friendly, understandable to a layperson with general IT awareness and if appropriate support was provided before they began using the system.
CDSCO is also seeking more in-depth responses on four broad subjects. These open-ended questions ask users for feedback on the major challenges and strengths of Sugam, the adequacy of the checklist for various applications on the portal and ideas for short- to long-term improvements of the system.
The consultation comes after CDSCO has worked through the teething problems that slowed the rollout of Sugam, enabling it to deploy the system across a wide range of critical regulatory processes. Gathering feedback on persistent shortcomings and opportunities for improvement could provide CDSCO with a roadmap for further development of the platform.
CDSCO is accepting feedback for two weeks.
CDSCO Notice
Indonesia Increases Oversight of Provincial Supply Chains to Catch Counterfeits
The Indonesian drug agency is expanding its presence outside the capital city in a bid to stop the spread of counterfeit medicines. Officials at the National Agency of Drug and Food Control (NADFC) devised the plan after seeing that people in remote areas think they can act with impunity.
Indonesia poses unique challenges to regulators. Most of the 263 million people in the country live in densely populated urban areas on the island of Java, where the Indonesian capital Jakarta and its more than 10 million inhabitants are located. However, the rest of the population lives in more rural areas on Java and the other islands in the archipelago that makes up Indonesia. 
NADFC thinks the trade in counterfeit drugs and other illegal activities under its jurisdiction may be fairly extensive in these more remote parts of the country, in part because people think their location cuts the risk of being caught. With NADFC’s resources focused on the urban areas of Java, people outside these cities saw the agency as posing little risk to their illegal operations.
Officials at NADFC want to dispel that impression and reduce the trade of counterfeit medicines. To do so, NADFC is opening offices outside the capital. The hope is that these offices will improve the compliance of distribution centers and other facilities in more remote parts of the country.
NADFC leaders discussed the offices at a workshop they see contributing to the effort to improve compliance with drug distribution rules and tackle counterfeiting. The workshop gave NADFC a chance to talk to its inspectors operating in districts and cities outside  Jakarta about their shared efforts to improve the standard of the drug distribution supply chain.
The Indonesian drug agency shared details of the workshop two days after it published details of the destruction of drugs in Banjarmasin, a city in the Indonesian portion of the island of Borneo. In the city of Banjarmasin, which is across the Java Sea from Jakarta, officials destroyed seized batches of several drugs with abuse potential, including the opiate tramadol. In total, the officials destroyed more than 10 million tablets.
NADFC Notice, More (both Indonesian)
China Approves Roche’s Biospecific Antibody to Treat Hemophilia A
China has approved Roche’s biospecific antibody emicizumab. The approval comes 13 months after the Food and Drug Administration (FDA) cleared the hemophilia A drug for sale in the United States.
Officials at the National Medical Products Administration (NMPA) have taken multiple steps over the past year to cut the time it takes for new medicines to come to market in China. The emicizumab approval adds to evidence that NMPA’s efforts are having an effect on the lag between when drugs come to market in China and the US.
Roche won FDA approval for emicizumab in November 2017 on the strength of two Phase III trials, neither of which enrolled patients in China. In December 2017, Roche initiated a Phase I trial to look into the pharmacokinetics, safety and tolerability of emicizumab in 16 healthy Chinese volunteers.
Roche is also running an open-label Phase III trial of emicizumab in hemophilia A patients in China and other Asian countries. However, the anticipated primary completion date of the Phase III is set for September 2019, suggesting NMPA approved emicizumab on the basis of efficacy data generated overseas and the small trial in healthy Chinese volunteers.
NMPA Notice (Chinese)


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