Asia Regulatory Roundup: India Revises Draft Biosimilar Guidance (5 July 2016)

Regulatory NewsRegulatory News | 05 July 2016 |  By 

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

India Revises Draft Biosimilar Guidelines, Drops Allowance of Parallel Trials

The Central Drugs Standard Control Organization (CDSCO) of India has revised its draft biosimilar guidelines published earlier this year. While most of the document is unchanged, CDSCO has made notable amendments on how clinical trials must be run and the situations in which comparative studies of biosimilars and reference products are needed.

CDSCO, in collaboration with India’s Department of Biotechnology (DBT), originally published the draft in March. That document expanded and tweaked guidelines from 2012, notably by giving companies the flexibility to use reference biologics not marketed in India, adding postmarketing requirements and waiving the need to run Phase III trials under certain circumstances. The comment period on the original draft closed on 30 April. Having reviewed the feedback, CDSCO has revised and republished the draft guidelines.

The changes remove some of the flexibility offered by the earlier draft. The revised guidance still offers a way for regulators to waive the need for biosimilar developers to run comparative safety and efficacy studies, but it reduces the number of situations in which such an approach is acceptable. CDSCO now states it will only allow waivers in “exceptional cases.” The regulator has also expanded the pharmacokinetic and pharmacodynamic criteria that must be met for a waiver to be granted, and said confirmatory safety and efficacy studies are mandatory for monoclonal antibodies.

CDSCO has hardened its approach to other aspects of clinical development, too. Whereas the March draft offered companies the opportunity to run a study in healthy volunteers in parallel to a Phase III safety and efficacy trial, the revised text only discusses a sequential development timeline. Under the sequential model, the study in healthy volunteers is run before the Phase III starts. When designing such Phase III trials, CDSCO wants biosimilar developers to consider the patient population the drug is tested in, a topic about which the earlier draft paid less attention.     

“The study should be conducted in a sensitive and homogenous patient population with appropriate sensitive primary end points as per requirement of a Phase III clinical trial,” CDSCO wrote.

Some of the other proposed changes relate to the selection of a reference biologic. Officials are now asking biosimilar developers to explain the rationale behind their choice of reference biologic in their submissions to CDSCO and DBT. The latest draft also features an updated definition of “reference biologic.”

Draft Guidelines

CFDA Sets out Application Process for Temporary Drug Import Licenses

China Food and Drug Administration (CFDA) has detailed when and how organizations can apply for a temporary drug import license. The document sets out the scope of CFDA’s one-time import licenses and walks through the process of obtaining such a regulatory clearance.

CFDA has created the one-time import license to enable companies to access drugs approved outside China in certain circumstances. The regulator will allow imports of such products when companies need them for registration purposes or to assess the quality and efficacy of generic drugs against their reference products. Senior officials in the Chinese government want to see such comparative assessments performed as part of a push to raise the standard of generic drugs sold in the country.

The guidelines on the one-time import process created by CFDA should ensure regulatory barriers do not prevent companies from carrying out comparative assessments. Companies that need to import a drug for such tests must complete an application CFDA released as an annex to its guideline. Once a form is submitted, the regional CFDA unit in charge of its assessment has five working days to decide whether to accept it for review and a further 20 days to rule whether to grant the license.

Applicants are expected to use their submissions to prove they are legally registered organizations and explain why they need access to a drug licensed overseas. CFDA is particularly keen to know the specific uses planned for the imported product and what quantity the company requires. Applicants must state in writing that they will only use the imported products for the purposes detailed in their submissions.

CFDA will issue rejection notices to any applications that fail to meet these requirements. Companies that are successful will receive an import license valid for a specific drug for 12 months. The license also details the accountability requirements associated with the regulatory clearance. Companies can expect their compliance with these requirements to be scrutinized. CFDA has asked its regional units to strengthen their supervision of organizations that have imported drugs for research purposes.

CFDA Notice (Chinese)

Indian State Blacklists Medical Company for Submitting Forged Documents

A government-owned procurement company in India has blacklisted a supplier for including forged documents in a tender proposal. Kerala Medical Services Corporation (KMSCL) took the action after receiving allegations of forgery that the company behind the submission was unable to resolve to its satisfaction.

The case centers on a document included in a submission for a contract to supply urodynamic study equipment. Interkardio Healthcare Technologies included the document to demonstrate it complied with a requirement in the tender relating to its market standing as of 2014. The document showed it supplied HLL Lifecare with products in April 2014. However, HLL subsequently contacted KMSCL to dispute the veracity of the supply order.

HLL argued the real supply order was dated April 2009 and was issued to Hospimedica International. KMSCL subsequently met with representatives of Interkardio to discuss the allegations, but left the meeting without evidence to demonstrate the veracity of the disputed document. The Interkardio representatives reportedly made allegations against other companies involved in the tender, but were unable to substantiate these claims.

KMSCL called a second meeting, but Interkardio failed to attend. This led KMSCL to blacklist Interkardio, an action that renders the company ineligible to participate in any of its tenders for the next three years.

PharmaBiz reports KMSCL has also taken action against a company thought to have forged labels to make it look like the shelf life of its products met the tender requirements. This company will also be blacklisted and have its existing supply contracts canceled.   

KMSCL Notice, PharmaBiz

TGA Releases Overview of Regulatory Fees and Charges

The Therapeutic Goods Administration (TGA) of Australia has summarized all of its fees and charges in a single document. TGA has created the document to provide a central overview of fees detailed in its various pieces of legislation.

Prior to the release of version 1.0 of the document this month, Australia lacked a single repository of all of the regulatory fees imposed by TGA. This forced firms regulated by TGA to look in texts such as “Therapeutic Goods Regulations 1990” and “Therapeutic Goods (Medical Devices) Regulations 2002” for information about the fees associated with regulatory processes.

TGA still recommends companies refer to the source legislation for the exact wording relating to a fee or charge, but they can use the summary to see how much each regulatory action costs. The summary covers all areas overseen by TGA, including prescription drugs, over-the-counter medicines, medical devices and pre-approval of advertisements.

TGA Document

Other News:

CDSCO has revised its policy on the transfer of staff. The policy prohibits staff from being posted to their home towns and from remaining in the same city or district for more than 10 years. CDSCO Policy



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