Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
China Changes Stance on Fake Drugs and Online Sales in Legal Update
China has passed changes to the drug administration law. The revised law, which will come into force at the start of December, requires online sellers of drugs to comply with certain rules and increases the maximum fine for organizations that make and market counterfeit medicines.
The National Medical Products Administration (NMPA) of China outlined implications of the new law after it was passed by politicians. Describing the process of drafting the new document as the second major revision in its 35-year history, NMPA highlighted the mix of attempts to encourage innovation, evaluate safety and efficacy across the life cycle and punish people and organizations that breach the rules in its overview of the legislation.
Many of the changes build on and formalize existing efforts already underway at NMPA, for example by positioning the regulator to improve the drug review system and prioritize candidates that address unmet needs.
Local media focused on the effect of the changes on the online trade in medicines and organizations caught breaking the rules, for example by selling fake drugs or manufacturing therapies without a license. The law significantly increases the potential penalty for wrongdoing, which will rise from five to 30 times the value of the goods involved when the changes come into effect later this year.
The sections on online medicine sales are intended to ensure e-retailers meet certain standards. The rules also prohibit online sales of certain types of therapies, such as vaccines, psychotropic drugs and narcotics.
TGA Restricts Use of Fentanyl Patches as Part of Anti-Opioid Abuse Push
Australia's Therapeutic Goods Administration (TGA) is set to restrict the use of fentanyl patches as part of a raft of measures intended to limit the harm caused by opioids. TGA decided on the actions after holding a public consultation last year.
Compared to the United States, harm caused by opioids is relatively rare in Australia. The number of daily doses of prescription opioids per million in Australia is around 40% of the level in the US. In Australia, three people a day die from drug-induced deaths involving opioid use. In the US, the figure is upward of 130 people, despite its population only being around 13 times the size of Australia’s.
Even so, the Australian government wants to curb misuse of opioids and enlisted TGA to help, leading to a public consultation on proposed regulatory actions last year. The feedback led TGA to advance a range of policies.
In its latest statement about the reforms, TGA said it plans to limit the use of fentanyl patches to the treatment of pain in patients with cancer, patients in palliative care and those in “exceptional circumstances.” The focus reflects TGA’s view that the potency of fentanyl makes it the top priority. TGA is changing the authorizations of all opioids to reinforce that they should only be used when other analgesics are proven to be ineffective.
The first batch of reforms also include changes to the size of packs given to patients. Currently, some patients are given a week’s supply of opioids despite only needing enough for two or three days. As this results in excess opioids in the community, which could be inadvertently or deliberately misused, TGA wants manufacturers to make smaller pack sizes available.
TGA is also working with manufacturers to add boxed warnings and class statements to the product information documents supplied with opioids. The new information will communicate the potential for harmful use of opioids. TGA is also planning changes to the consumer medicines information.
The changes will start to come into effect in January, beginning with the registration of smaller pack sizes. TGA expects to limit the indications in which fentanyl patches are used in the first half of 2020, with further changes to follow in a phased manner that reflects the large number of opioids sold in Australia and worries about the potential for reforms to cause unintended harm.
Those worries were expressed by respondents to the consultation including the Royal Australasian College of Physicians (RACP), which raised “significant concerns” about the scope for harm to come to “many patients.” RACP was among the organizations involved in an advisory group TGA set up after the consultation to mitigate such risks.
India Extends Deadline for Manufacturers of Rational FDCs to Seek Clearance
The Central Drugs Standard Control Organization (CDSCO) has given producers of certain fixed-dose combinations (FDC) more time to seek nationwide licenses. CDSCO originally gave manufacturers of the 83 FDCs until late June to submit the filings but has now extended the deadline to December.
The deadline affects manufacturers of 83 FDCs that were caught up in the attempted crackdown on irrational FDCs, which were only to be deemed rational in a subsequent assessment. That assessment led Indian authorities to permit the FDCs to remain on the market. However, as the FDCs came to market via a state-level back door, Indian officials told the manufacturers to seek nationwide authorization.
That was in late February. At that time, CDSCO gave the manufacturers four months to submit the required information. CDSCO warned the manufacturers that it would not consider applications that arrived after the deadline, adding that their “licenses will be considered as without legal validity.”
Now, CDSCO has softened its stance. Having received “various representation” regarding the topic, CDSCO has pushed back the deadline until 2 December. CDSCO wants manufacturers to include the fees requested in the relevant part of the New Drugs and Clinical Trial Rules, 2019.
CDSCO Clarifies Rules on Importing Drugs for Use in Academic Clinical Trials
CDSCO has clarified the rules on organizations that want to import drugs for use in academic clinical trials. The regulator will waive the need to obtain an import license provided certain conditions are met.
Under the New Drugs and Clinical Trial Rules, 2019, academic clinical trials are defined as studies in which an investigator, academic or research institution explores the use of an existing drug in a new context. Clinical trials of existing drugs in new indications, routes of administration, doses and dosage forms qualify, provided the study is not intended to support a filing for approval.
Trials that meet those criteria benefit from slightly different regulatory requirements, including a relaxing of the rules on seeking import licenses. CDSCO explained this week that a copy of the ethics committee approval, stating the quantity of drug being imported and why, can serve as clearance for importation, freeing sponsors of academic studies from the need to obtain a Form 11 license.
has released promotional materials designed to encourage people to report adverse events. The creation of the consumer-focused materials follows a period in which members of the public have accounted for a falling proportion of adverse event reports submitted to TGA, largely as a result of an uptick in the number of submissions by groups including companies and doctors. TGA Notice
has released an overview of upcoming consultations. The agency expects to start four public consultations next month, including a review of proposed changes to medical device conformity assessment procedures. TGA has three other consultations in the pipeline, one of which will cover 2D barcodes for medicines. TGA Notice