Asia Regulatory Roundup: TGA Mulls Disclosing Drug Approval Filings to Further Transparency Agenda

RoundupsRoundups | 19 February 2019 |  By 

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.
TGA Mulls Disclosing Drug Approval Filings to Further Transparency Agenda
Australia’s Therapeutic Goods Administration (TGA) is considering disclosing when it is evaluating a filing for approval of a prescription drug. TGA currently only shares details of submissions once it has finished evaluating them, but is open to changing its position to make the process more transparent.
Australian officials adopted their current position in the belief that applicants should decide whether it is prudent to reveal details of an application for registration, as the information has commercial value. TGA defended its position in court around the start of the decade when iNova Pharmaceuticals requested documents relating to applications for approval of generic versions of its drugs.
TGA won the legal dispute, allowing it to keep the documents private, but is now voluntarily weighing the merits of adopting a more transparent model. The agency framed the rethink as part of a broader move toward transparency and a way to ensure patients can access useful information.
“Availability of information is a cornerstone of informed decision making,” TGA wrote in a paper on the proposed changes. “From a patient perspective earlier knowledge about potential availability of treatments, should they be approved, may be considered as part of discussion about options for medical treatment and care with their healthcare practitioners.”
To help it assess whether such considerations should outweigh industry-focused factors, TGA has put forward four possible approaches to the disclosure of filing information for consultation. These range from the maintenance of the current, opaque status quo through to the disclosure of details of all filings for approval of new chemical entities (NCEs), line extensions, generics and biosimilars upon TGA accepting them for evaluation.
TGA listed transparency and consistency as benefits of the full disclosure approach but warned that it may discourage generic companies from making applications until their legal position is clear. That could delay the availability of cheaper generics to the Australian healthcare system.
In light of these perceived shortcomings of the full disclosure approach, TGA has proposed two other options that fall short of total transparency. One option is to release details of filings for approval of NCEs and indication extensions when they are accepted but hold back information on generic drugs until the submission is approved.
The two-tier system reflects a belief that there is more public demand for information about NCEs than generics. That same line of thinking underpins the fourth proposal, which would see TGA share details of NCE filings upon acceptance for evaluation but continue to withhold information about generics. TGA cites the public demand for information about Biogen’s spinal muscular atrophy drug Spinraza as evidence of why it is considering sharing more details about innovative medicines.
TGA has asked interested parties which of the options they support and sought suggestions about how they could be improved. The request for feedback also addresses what details, such as sponsor name and indication, should be disclosed in the event TGA does start releasing more information.
The consultation is open until 29 March.
TGA Consultation
Drugmakers in Singapore to Get Greater Access to EU as Trade Deal Advances
Drugmakers in Singapore are set to gain greater access to the European Union as the result of a trade deal that took a big step forward this week. The trade deal will eliminate tariffs on medicines and reduce non-tariff barriers through mutual recognition of regulatory standards.
Singapore and the EU struck the trade deal in 2012, but the agreement was then derailed by a court case over the role the parliaments of European member states should play in the ratification process. That delayed the ratification process, resulting in the European Parliament only getting to vote on the deal this week. The Parliament passed the deal by 425 votes to 186, with 41 abstensions.
The deal still needs to be concluded by the European Council, and certain aspects of the agreement must be ratified by member states. The big delays now look to be behind the deal, though. If all goes to plan, the trade agreement could come into effect this year.
Once the deal comes into force, several key aspects of the trade and regulation of pharmaceuticals, medical devices and active pharmaceutical ingredients (APIs) will change. As soon as the agreement comes into force, the EU and Singapore will stop imposing custom duties on pharmaceuticals shipped from the other territory.
In parallel, the EU and Singapore will work to eliminate non-tariff barriers to trade. Singapore already offers foreign companies easy access to its domestic market. However, the companies that make up Singapore’s S$17 billion ($13 billion) pharmaceutical manufacturing industry face non-tariff barriers to the EU market. Facets of the deal designed to eliminate these barriers include EU recognition of Singapore’s good manufacturing practices. That change is expected to encourage trade in APIs.
The agreement also commits the EU and Singapore to the use of international standards, practices and guidelines, particularly texts developed by international bodies. Both sides have also committed to ensuring listing, pricing and reimbursement practices for pharmaceuticals are “fair, reasonable and nondiscriminatory.” Another section of the trade deal features provisions to protect data submitted in filings for approval of medicines.
Press Release, Deal Summary
China Bans Production and Sale of Antimicrobial Agent, Orders Recall
China’s National Medical Products Administration (NMPA) has banned the production and sale of the antimicrobial agent furazolidone. NMPA took the action in response to concerns about severe side effects linked to products containing nitrofuran.
Products containing the antimicrobial came to market in China in the 1970s as treatments for gastrointestinal infectious diseases caused by bacteria and protozoa. More recently, the ingredient has been linked to severe skin reactions and disorders affecting the peripheral nerves, leading NMPA to reassess whether the benefits still outweigh the risks.
This week, NMPA concluded that the risk-benefit profile no longer supports the continued use of the ingredient. Having reached that conclusion, NMPA has ordered manufacturers of products containing furazolidone to cease production and sales. NMPA has given the manufacturers until the end of next month to recall their products. The authorities will then supervise the destruction of the products. NMPA’s action affects 15 products manufactured by multiple Chinese companies.
The order to cease production is part of an ongoing global reassessment of the merits of products featuring furazolidone. The ingredient featured in some of the fixed-dose combinations the Indian government deemed to be irrational, and was included in a list of veterinary drugs consumer groups asked the United States Food and Drug Administration (FDA) to ban in 2013. FDA pulled new animal drug applications for furazolidone in 1991 but continued to permit some use of nitrofurans.
NMPA Notice (Chinese), FDA Letter
Other News:
Indonesia is set to delay the implementation of rules requiring products to be labeled as halal or face bans, according to Reuters. The world’s biggest Muslim-majority country was set to implement the halal labeling requirements this year. However, the government has faced pushback from multiple industries, including the vaccine manufacturing sector, amid fears the requirements will put supplies of life-saving products at risk. The pharma sector may now get until 2026 to comply. Reuters
China has floated plans to reduce value-added tax on certain rare disease drugs, BioCentury reports. The change would cut the tax rate from 16% to 3%. BioCentury


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