Asia-Pacific Roundup: New Zealand clarifies acceptable overseas evidence of GMP in updated medicine guidelines

The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has published the fifth version of its guidelines on the manufacture of medicines. Medsafe used the update to clarify examples of acceptable evidence from audits by authorities in the United States and European Union.

New Zealand accepts any good manufacturing practice (GMP) certification document issued by a recognized authority that confirms compliance. The updated guidelines expand the list of recognized authorities to include Bulgaria, Croatia, Cyprus, Estonia, Latvia, Lithuania and Slovenia, and clarify the information about using evidence from US Food and Drug Administration (FDA) audits.

Medsafe’s list of examples of acceptable evidence of GMP certification includes a letter or file note from a recognised authority confirming GMP compliance. In an accompanying explanatory note, Medsafe names “an extract from FDA files obtained by the manufacturer under the Freedom of Information Act” as an example of such a letter or file note.

“The extract usually states that an audit occurred on the given date and gives the outcome of the audit. This should include evidence of the scope of the audit. In some instances unredacted reports may be sent directly to Medsafe, in confidence,” the guidelines state.

Medsafe also clarified the requirements for certificates published in EudraGMP, the EU’s database of manufacturing authorizations and of certificates of GMP compliance. Unlike most forms of evidence, current EudraGMP certificates do not need a date and signature.

Medsafe Guidelines

India puts regulations that facilitate R&D at heart of new policy on pharma and medtech

India’s Department of Pharmaceuticals (DoP) has released the National Policy on Research & Development and Innovation in the Pharma-Med Tech Sector in India. In the document, DoP identifies the need for a regulatory environment that “facilitates innovation and research in product development.”

Indian officials are concerned about “the relatively low pace of development of biologics, biosimilars and other emerging products/trends” and see the innovation policy as a way to “help enhance domestic availability and affordability of these categories of new age therapeutics.” The concern informed the decision to make enabling “rapid drug discovery and development and innovation in medical devices by streamlining of regulatory processes” the first objective of the policy.

In discussing how the policy can achieve its objectives, DoP named creating “a regulatory environment that facilitates innovation and research in product development, expanding the traditional regulatory objectives of safety and quality” as the first area of focus. The focus reflects a belief India’s regulatory frameworks “do not necessarily differentiate in favor of innovation.”

“Another major challenge lies in building regulatory capacity within the government to keep up with the latest advances in science and technology and reduce dependence on ad-hoc external inputs. All of this contributes to long timelines for grant of approval to innovative products, which has been identified as an area of concern,” the DoP wrote.

The department is considering four measures to “create a regulatory bias in favor of innovation and original research.” The four measures are: process optimization; technology-based platform; regulatory capacity; and legislation. The policy includes a short description of DoP’s plans in each area.

To optimize processes, the government plans to explore a mechanism “that will mandate all the regulators to work together to reduce process overlapping and establish timelines for requisite approvals.” The goal is to cut the time taken to approve innovative products by at least 50% in the next two years.

On the technology front, DoP wants to create “a single end to end digital portal” that different Indian departments and regulators will use to interact with applicants. The aim is “to bring transparency, timeliness and predictability to processes and outcomes around regulation.”

To enhance regulatory capacity, officials want to build in-house expertise in emerging areas such as biologics, artificial intelligence and sensors. DoP said the National Pharmaceutical Pricing Authority will “develop greater expertise in the pricing of new innovative products while pursuing affordability as an overall objective.” Collaboration with international regulators is part of the plan.

In terms of legislation, the government is considering reviewing all the laws that affect pharma and medtech R&D “to identify areas of friction and design tenable solutions.” DoP highlighted “differentiated handling of research in products that are cultured and cultivated artificially, increasing the number of bodies that can approve pre-clinical trials, enabling joint inspections and licensing mechanisms for traditional medicinal products” as potential areas of focus.

DoP sees changes to the regulatory environment as a way to facilitate its other objectives. The policy names regulatory complexity as a barrier to private investment in innovation, a core goal, and discusses the need to develop a “talent ecosystem” that creates a medical device workforce that includes people with “knowledge of navigating regulatory policies.”

The government published the document alongside a Scheme for Promotion of Research and Innovation in Pharma MedTech Sector (PRIP). The PRIP scheme is focused on “strengthening the research infrastructure in the country” and covers topics other than regulation.

R&D Policy

Malaysia’s MDA seeks feedback on regulatory requirements for wearable medical devices

Malaysia’s Medical Device Authority (MDA) has published draft guidance on wearable medical devices. MDA is collecting feedback on its proposed approach to the regulation of the emerging device category.

The authority defines wearables as “a type of technology that is incorporated in electronics that can be worn on the body, either as an accessory or as part of materials used in clothing,” adding that the ability to connect to the internet to exchange data is one of the major features of the category. That definition covers “general wellness products” and medical devices.

MDA’s draft addresses how to determine if a wearable is a general wellness device, and therefore outside of the scope of the guidance, or a regulated medical device. A product is a medical device if it meets the definition given in the Medical Device Act 2012.

“In the case of products that are intended by the manufacturer to be used for wellness but are able to perform medical function or purposes, the manufacturers are required to include a statement or equivalent on their labels to clearly inform the users not to rely on the results of wearable products as a medical diagnosis and consult a healthcare professional for further action,” MDA wrote.

The guidance also lists the existing regulations that apply to wearable medical devices and provides examples of wearable medical devices and general wellness products. MDA is accepting feedback until 8 September.

Draft Guidance

TGA prepares industry for upcoming changes to medicine shortage requirements

Australia’s Therapeutic Goods Administration (TGA) has discussed the changes to the drug shortage reporting requirements that will take effect on 22 September.

From that date onward, companies that supply medicines in Australia will need to specify the period of each medicine shortage. Legislators mandated the reporting of shortage duration by updating the Therapeutic Goods Act 1989 earlier this year but gave sponsors six months to “refine their internal shortage reporting processes to manage the change.”

TGA told sponsors they will need to report changes to the shortage duration or end date and resolution of the shortage; the period of the shortage of the medicine in Australia; and any changes to the period and resolution date where the medicine shortage period ends on or after 22 September, regardless of when the shortage was first notified.

TGA Notice

Asia-Pacific Roundup: New Zealand clarifies acceptable overseas evidence of GMP in updated medicine guidelines

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