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Posted 18 July 2017 | By Nick Paul Taylor
Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
Pfizer and Sanofi have told the Therapeutic Goods Administration (TGA) its planned changes to the rules governing complementary medicines will increase regulatory burdens. The two big pharma companies were among the organizations to raise concerns proposed changes to TGA assessment pathways and other reforms will increase burdens while decreasing flexibility.
Australia's TGA proposed the reforms to give sponsors of traditional or alternative medicines the flexibility to target more indications than is possible under the existing framework. Today, sponsors of low-risk products follow the listed pathway. Sponsors of high-risk products follow the registered pathway. TGA is proposing a third pathway that sits between these two routes to market to enable sponsors to target higher-level indications without going through the full drug approval process.
Some companies and trade groups think TGA's reforms will fail to deliver against its objectives. The definitions of the three post-reform pathways are one perceived problem. Organizations including Pfizer and Sanofi support the creation of a third pathway. However, the reform is seen as placing additional regulatory burdens on some complementary medicines with a long history of use that today are classed as listed medicines. This runs counter to the stated objectives of the reforms.
Both the large pharma companies to comment on the TGA proposals also mentioned a disconnect between the post-reform evidence requirements of complementary and over-the-counter (OTC) medicines.
"Pfizer does not support the proposed evidence requirements as these are also inconsistent with the recommendations and introduce a disproportionate evidence requirement for each assessment pathway. The evidence requirements proposed in the [complementary medicine] reforms are significantly higher ... than those required for OTC medicines," the drugmaker wrote in its feedback to TGA.
Sanofi also voiced concerns OTC medicines will face an easier regulatory pathway despite being higher-risk products.
The companies were similarly united in their views on the potential for another change to upset the balance between OTC drugs and complementary medicines. TGA is proposing to allow sponsors of complementary products that follow the two more rigorous pathways to claim the efficacy of their medicines have been assessed.
Pfizer and Sanofi fear such claims will make complementary medicines appear to be of a higher standard than registered OTC products. OTC medicines cannot make such claims despite passing through pre-market assessments of quality, efficacy and safety.
TGA is still planning to introduce the "claimer" and enact some of the other contentious reforms, but is modifying its approach in some areas. Further consultation on some topics, including the efficacy "claimer," are planned before TGA adopts a final position.
Pfizer, Sanofi, TGA Response
The Drug Controller General of India (DCGI) is allowing companies to apply stickers to products to head off shortages of essential medicines. Companies sought the regulatory flexibility to mitigate the effect of the recently introduced goods and services tax (GST) on the supply of drugs in India.
India adopted a 12% GST tax on most medicines on 1 July. GST for some vital medicines, such as insulin, was set at 5%. Both tax rates differ from the 9% charge the Indian government previously applied to medicines. The tax reform therefore affected the price of medicines. As some medicines ship with the maximum retail price printed on their packaging, this raised concerns DCGI would force manufacturers to recall products that have out-of-date pricing information.
DCGI Dr. GN Singh has opted against taking this approach. After receiving a representation from the Federation of Indian Chambers of Commerce & Industry (FICCI), Singh decided to allow companies to apply stickers to their product packaging to correct obsolete pricing information.
Singh's allowance of the quick fix to issues arising from the implementation of GST removes a barrier that could affect the supply of medicines. If companies had to repackage their products or individually seek special dispensation from DCGI, drug shortages could have arisen. Some reports suggest GST had already affected the supply of essential medicines to treat diabetes and other diseases. The stickering rule is intended to prevent further shortages.
DCGI Notice, More
DCGI is seeking feedback on plans to expand use of the Sugam online portal to other regulatory services. The list of regulatory filings set to be added to the portal following the consultations include processes for new drugs.
Officials plan to gather feedback on online processes for new drugs, fixed-dose combinations and subsequent new drugs at a meeting on 25 July. Before then, DCGI will hold sessions on the four other areas set to become part of Sugam. The other submissions set to transition to Sugam include serious adverse event reports and the registration of drugs intended for export.
The development of modules for these filings that are ready to demonstrate to the industry follows the phased rollout of the portal in other areas. This year, DCGI has added vaccine filings and requests for written confirmation of clearance to export active pharmaceutical ingredients to the European Union to the list of regulatory processes that use the portal.
Adding the latest modules to the portal will advance Singh closer to his goal of moving all regulatory services online. Singh stated that objective in 2015, but his team has proceeded cautiously. The rollout of Sugam began late in 2015 with modules covering registration certificates and import licenses.
The China Food and Drug Administration (CFDA) has created a service companies can use to book appointments online. CFDA is encouraging companies to use the online platform when they need to meet with its experts to discuss their operations.
Companies that want to use the online booking service must register first. Once the registration is approved, the company can use a CFDA site to book appointments. The company's representative then turns up at the allotted time with a valid identification card and gets to talk to CFDA officials.
CFDA framed the introduction of the portal as part of China's attempt to use the internet to improve the efficiency of government services. The agency is wary of the potential for the portal to have unintended consequences, though. CFDA will freeze the accounts of firms that repeatedly fail to give it enough warning of meeting cancellations or do not show up at the allotted time.
That punishment is intended to ensure companies treat appointments made online as they would meetings scheduled through traditional channels.
CFDA Notice (Chinese)
TGA is set to remove the "standard conditions" section from Australian Register of Therapeutic Goods (ARTG) medical device certificates. The conditions cover storage and transport, record keeping, annual reporting and notification of information. Following the change, the conditions will be covered in therapeutic goods regulations. TGA thinks this will ensure consistency and make it less "technically and administratively difficult" to update the conditions. TGA Notice
TGA has released a statement about the United Kingdom's Medicines and Healthcare products Regulatory Agency's (MHRA) revised advice about metal-on-metal hip replacements. The Australian regulator said its earlier recommendations remain appropriate in light of the MHRA's updated position. TGA performed similar reassessments following the actions of overseas agencies in 2014. TGA Statement
Tags: Asia Regulatory Roundup, Regulatory Roundup
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