Asia Regulatory Roundup: Pakistan Posts Draft Accelerated Approval Guidances

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Pakistan Posts Draft Accelerated Approval Guidelines in Flurry of Activity
 
The Drug Regulatory Authority of Pakistan (DRAP) has published draft guidance on its priority review and accelerated approval processes. DRAP released the guidelines alongside a clutch of other guidance documents covering topics including pharmacovigilance and post-registration variations.
 
Like many other regulators, DRAP is open to offering certain drugs a streamlined path to market to ensure patients get timely access to particularly important therapeutic interventions.
 
“DRAP recognizes that there are circumstances in which standard requirement and procedure for registration / market authorization may be challenging to fulfill and there is an unmet need of such drugs in the country. In such situations, DRAP supports the availability through registration of drug products that address the unmet medical needs in special situations,” the agency wrote.
 
The guidelines published this week set out what that position means in practice for drug developers. DRAP has created two pathways with similar objectives. One pathway provides for priority review of medicines, the other facilitates conditional marketing authorizations. DRAP wants drug developers that are interested in using either pathway to file requests before making their applications.
 
DRAP will review the requests against its eligibility criteria. One set of criteria applies to both pathways. Those criteria cover whether the benefits outweigh the risks, the unmet need being addressed, the pros and cons of making the drug available immediately and the applicant’s ability to provide comprehensive data.
 
The agency has also created criteria specific to the priority review and conditional approval pathways. Criteria for the priority review pathway include the rarity and severity of the targeted disease. The conditional approval criteria limit use of the pathway to new products that treat, prevent or diagnose seriously debilitating or life-threatening diseases and medicines required for use in a public health emergency.
 
DRAP will make decisions on products granted priority review within 150 days, the same timeframe the European Medicines Agency uses for its accelerated assessment program. DRAP is encouraging companies that plan to seek conditional approval to also request a priority review. The conditional approval pathway offers companies a way to get drugs to market on the basis of limited data but has no direct effect on review times.
 
The draft guidelines went online around the same time as three other documents. The other draft guidelines cover post-registration variations and summary of product characteristics (SmPC). DRAP is accepting comments on the draft guidelines for 15 days. The agency also released final guidelines on pharmacovigilance.
 
Approval Guidelines, Variation Guidelines, Pharmacovigilance Guidelines, SmPC Guidelines
 
Professional Bodies Push Back Against TGA Plan to Upclassify Medical Devices
 
Professional bodies have pushed back against parts of the Therapeutic Goods Administration’s (TGA) planned upclassification of whole categories of medical devices. The Australian regulator proposed treating all substances delivered via a body orifice or applied to the skin as at least Class IIa devices.
 
Setting out its position in a consultation document in March, TGA argued such devices “potentially present a higher level of risk, as once the device is absorbed or dispersed in the body, its effects may not be easily reversed or ceased if these devices do not perform as intended.” The proposal is part of TGA’s ongoing efforts to align itself with the changing European Union medical device rules.
 
The planned blanket upclassification of certain types of devices has encountered resistance. The Royal Australian and New Zealand College of Ophthalmologists wrote to TGA to request that eye irrigation products are treated as Class I devices “since they are not intended for absorption into the body.” A dental organization made a similar case for certain types of toothpaste and lozenge.
 
The Australian Self-Medication Industry framed similar concerns more broadly, arguing that the rule on which products are classified needs discussing and clarifying. The trade group pointed to the extent of systemic absorption as one area in which further guidance is needed.
 
TGA referred to the concerns of the dental and ophthalmology sectors in its summary of the feedback. The agency is yet to publicly detail how the feedback will shape its final position. That will become clearer as TGA releases guidance on which products are subject to reclassification.
 
Collated Feedback
 
TGA Creates Guidance on Difference Between Disease Education and Drug Promotion
 
TGA has published guidance for providers of disease education activities. The guidance is intended to help such organizations to continue raising awareness of diseases without violating TGA restrictions on the promotion of therapeutic goods.
 
Disease awareness was a source of disagreement between TGA and the industry when the agency set out its planned changes to the advertising code late in 2017. Trade group Medicines Australia warned TGA’s planned ban on naming a “specific therapeutic good or sponsor either expressly or by implication” in disease awareness campaigns risked disrupting educational initiatives and reducing transparency.
 
TGA revised its position in response to industry feedback but remains concerned about the potential for disease awareness campaigns to promote therapeutic goods, either deliberately or inadvertently. In light of those concerns, TGA set out its position on a guidance document. 
 
“While a disease education activity may make reference to a range of treatment options, if the information provided is likely to encourage consumers to seek to obtain a particular good, or seek a prescription for a particular medicine, then it will be considered an advertisement,” TGA wrote in the guidance it published this week.
 
As TGA notes, that position creates particular challenges for companies that want to raise awareness about diseases for which there are limited treatments. The limited number of treatment options for a particular disease means educational information “may draw attention to one specific therapeutic good, whether that good is named or not.”
 
TGA Guidance
 
China’s NMPA Grants Conditional Approval to Alzheimer’s Disease Drug
 
China’s National Medical Products Administration (NMPA) has granted conditional approval to a drug to treat mild to moderate Alzheimer's disease. The drug, Oligomannate, originated in China and got NMPA backing on the strength of data from a Phase III clinical trial in the indication.
 
Oligomannate is a low molecular acid oligosaccharide compound extracted from marine brown algae that was discovered at the Chinese Academy of Sciences Shanghai Institute of Materia Medica. Shanghai Green Valley Pharmaceuticals took the asset forward, putting it through a late-phase trial that linked it to a statistically significant improvement in cognitive function. The improvements started after one month of treatment and continued throughout the nine-month clinical trial.
 
NMPA deemed the data strong enough to support conditional approval after assessing Oligomannate under its fast-track review program. However, NMPA has placed conditions on the approval. Green Valley will need to gather long-term safety data and continue researching the drug’s pharmacological mechanisms.
 
Having secured the conditional approval, Green Valley plans to start selling the drug in China by the end of the year. Green Valley also has plans to bring Oligomannate to global markets. A Phase III trial featuring sites in the United States, Europe and Asia is due to start early next year and generate data to support international filings.
 
NMPA Notice (Chinese), Press Release
 
Other News:
 
TGA has released guidance on seeking consent to supply therapeutic goods that do not comply with subsection 9(2) of Therapeutic Goods Order No. 92. The order relates to having the name of a medicine on a product label. TGA Guidance