Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Starts Accepting Priority Review Notifications, Implements Revised Orphan Drug Program
The Therapeutic Goods Administration (TGA) of Australia has opened its priority review pathway. TGA is now accepting notifications from sponsors who plan to apply for priority review status to accelerate the approval of their medicines in the coming months.
Officials at TGA are “strongly” encouraging sponsors to submit notifications of interest in the pathway at least one month before they file the actual application for priority review designation. The gap between the filing of the notification and the application means TGA has started accepting the former type of submission before the pathway formally goes live on 1 July. TGA plans to start accepting the applications in August.
Successful applicants will benefit from expedited reviews. TGA is aiming to process applications for the approval of drugs with priority review status within 150 working days, around five months. Standard reviews take up to three months more.
The pathway is open to drugs that target a serious condition with unmet medical need. TGA also expects applicants to provide data showing their drug is a major advance over existing treatments. Applicants will also need a full dataset when they come to file for approval. TGA has designed the pathway to speed the approval of drugs that have been through a full clinical trial program, rather than provide an abbreviated development pathway.
Implementation of the pathway formalizes what was previously an ad-hoc approach to expediting reviews. Under the drug registration system TGA adopted in 2010, applicants could not request priority review status and there was no formal pathway. Explaining the decision at the time, TGA said, “The registration process relies on the advance allocation of resources to evaluate applications, thus limiting opportunities for conducting evaluations any faster than the standard registration process.” When possible, TGA tried to cut processing times for significant drugs.
The adoption of a formal pathway is one of many major changes in the works at TGA. Another of the first wave of changes covers orphan drugs and is also due to come into force on 1 July. TGA is revising its 20-year-old approach to orphan drugs to align it more closely with global practices.
Sponsors applying for orphan status after 1 July will benefit from a higher prevalence threshold. This means indications that were previously too common to be classed as rare diseases in Australia will now be eligible. TGA has simultaneously tightened up the criteria in other areas, notably by requiring that a drug treats a seriously debilitating or life-threatening to be eligible for orphan status.
Priority Review, Orphan Drug
CFDA Claims Success in Mission to Reduce Once-Sprawling Backlog of Applications
The China Food and Drug Administration (CFDA) has claimed success in its battle to reduce its backlog of applications. A CFDA leader told a government committee the backlog now stands at 6,000 applications, down from 22,000 at its peak in 2015.
State news organization Xinhua wrote up the comments in an article subsequently republished by CFDA. The regulator has enacted multiple strategies over the past few years to cut the time it takes for innovative drugs to come to market in China. Of these, the attack on the quality of applications for generic medicines was the strategy aimed most directly at the backlog.
When CFDA ordered applicants to self-audit their data in 2015, some observers thought that at least half of all filings were based on forged results. CFDA gave an easy out to companies seeking approval on the basis of dodgy data by allowing them to withdraw their applications without being punished. More than 1,000 applications were withdrawn.
In parallel, CFDA enacted guidance designed to raise the standards by which generic drugs are developed, manufactured and assessed in China. This action is primarily intended to improve the quality of generic drugs sold in China but it may also deter companies with substandard practices from seeking approval.
Xinhua cited these initiatives in its explanation for how CFDA has reduced its backlog. The news agency also highlighted the priority review system established by CFDA. If this functions as hoped, it will enable companies developing drugs with significant therapeutic potential to avoid getting stuck in the still-substantial backlog of applications.
CFDA Notice (Chinese)
Indian Pharma Department Creates Unit to Help Industry Through Major tax Reforms
The Indian Department of Pharmaceuticals has created a unit to help the industry adapt to major tax reforms the government is introducing on 1 July. Officials want the unit to serve as a first point of contact for companies that face problems in moving to the 12% goods and services tax (GST).
GST represents a tax increase for most pharmaceutical products. Today, drugs are taxed at 9%. From 1 July, the rate on most drugs will rise to 12%. The government is treating drugs it views as vital, such as insulin, differently. A 5% tax rate applies to these drugs.
In the days before the implementation of the tax, media reports suggested the industry was still unsure how the tax would affect aspects of their operations. A representative of Indian trade group Pharmexcil told The Times of India the move to the new tax rate could create issues with the printing of maximum retail prices (MRPs) on drug packaging. The representative hoped regulators would shy away from insisting on the recall of products with MRP-related errors.
Another concern is that drug shortages will occur as distributors and retailers run down their inventories in an attempt to minimize losses. There are conflicting reports about whether this is a real concern. One pharmacy chain advised customers to buy drugs in advance of the GST deadline to avoid shortages in July. However, an assessment by the All India Organisation of Chemists and Druggists found that, while stocks are lower than usual, shortages are unlikely.
The Department of Pharmaceuticals hopes its GST unit will mitigate the impact of the transition. The unit is made up of two deputy secretaries and an economic advisor to the department.
DoP Notice, The Times of India, Livemint, More
TGA Adds $1,500 to Regulatory Fees for Certain APIs to Correct Historic Undercharging
TGA has added AU$2,030 ($1,540) to its fees for compliance verification (CV) good manufacturing practice (GMP) clearance applications covering certain drug ingredients. The extra charge is tied to TGA’s decision to apply CV fees to non-sterile active pharmaceutical ingredients (APIs).
Officials said the historic decision not to apply CV fees to these APIs resulted in TGA failing to recoup its outlay on handling such GMP clearance applications. The change is intended to correct this historic undercharging.
TGA will begin applying the fee to all CV GMP clearance applications from 1 July. That is the same day TGA’s 2017-18 fee schedule comes into force. The new schedule increases the CV fee from AU$2,000 to AU$2,030.
TGA Statement, 2017 Fees
has become a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use
(ICH). ICH accepted CFDA into its ranks at a meeting in Canada earlier this year. The acceptance of CFDA means ICH now has 14 members. In recent years, CFDA has begun to align its guidance with ICH documents. CFDA Notice