Dr. Naheed Ali, MD, PhD

Obtaining approval for drugs and medical devices to be used in other countries is critical for a variety of reasons. Once the safety and efficacy of these products have been established in their home country, getting them approved for use in another country allows manufacturers to expand access to them. It also increases market competition, driving down prices and making high-quality healthcare more affordable for more people. However, the journey to this esteemed approval is not a smooth-sailing one.

The Regulatory Process in a Nutshell

The drug and medical device regulatory process is a complex and highly regulated area that varies from country to country.

From the Country of Origin to the Target Country

Companies interested in distributing their products abroad must first submit their product to the Food and Drug Administration (FDA), who will then provide written authorization for international distribution. The company can then consult a regulatory consultant who can help them establish relationships with regulatory agencies and other stakeholders in other countries, and advise them on the specific regulatory requirements and standards that must be met.

One important aspect of the approval process is the translation of all relevant documents into the language of the target country. This is crucial because the regulatory agency in the target country will need to be able to understand and evaluate the information provided in the application, and the clinical trial protocols and consent forms used in the trials must also be translated so that the participants can understand the risks and benefits of participating in the trial.

Foreign Regulatory Processes

The regulatory process for drugs and medical devices varies from country to country. In general, however, most countries have a regulatory agency that is responsible for evaluating and approving these products for use within their borders. This agency will review the applications from manufacturers and conduct their own studies to ensure that the products are safe and effective for their intended use. If the product is approved, it will be granted a license to be sold and used in the country.

For example, in the European Union, the European Medicines Agency (EMA) is responsible for evaluating and approving drugs and medical devices for use in all EU member states. The EMA uses a centralized approval process, which means that manufacturers only need to submit their applications to the EMA rather than to each individual country. This centralized approach is likewise used by Canada, where drugs and medical devices need only to submit their applications to Health Canada, the country’s federal department responsible for public health, rather than to each individual province or territory.

Current Trends and Challenges in Regulation

The regulatory process is a dynamic one: as the products evolve, so do the processes for their approval, which can pose obstacles to manufacturing companies.

Regulatory Harmonization

The increasing pressure to bring new treatments and technologies to market quickly while also ensuring their safety and effectiveness has led to a focus on streamlining and improving the efficiency of the regulatory process through harmonization. It was for this reason that the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) was established in 1990.

The ICH has put out quality, safety, efficacy, and multidisciplinary guidelines which are recognized by many countries. Despite this, country-specific regulations do still exist, such as those among the constituents of the Association of Southeast Asian Nations (ASEAN). This is due in part to differences among the countries’ local regulatory agencies, their structure and processes, their relationship with external stakeholders, and individual thresholds for risks and benefits.

Transparency amid Globalization

A complicated network of suppliers, manufacturers, sponsors, and marketers has emerged due to the globalization of the pharmaceutical supply chain, making it vulnerable to poor regulation, trade wars, and the prioritization of corporate or individual interests.

The growing importance of patient engagement and input in the regulatory process, as well as the need to consider the broader societal and ethical implications of new drugs and medical devices, has led to a greater emphasis on transparency and public participation in the regulatory process.

Maintaining High-Level Communication across Borders

Effective communication is one of the most important aspects of getting drugs and medical devices approved abroad. Translation and back translation can help to support the approval process by ensuring that the necessary information and materials are accurately translated and can be understood by the regulatory agency. They are especially important for countries that require all submissions to their regulatory agency to be in their native language, such as in Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA).

ANVISA’s website, which details the process for foreign product approval and distribution, is available in both English and native Portuguese. However, the English version’s content is limited and does not include all the pertinent data that is provided in the Portuguese version. In such cases, the manufacturers also rely on translators to unravel and decipher the local regulatory, testing, and pharmacovigilance processes.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) similarly requires all regulatory submissions to be in Japanese. To encourage foreign manufacturers to enter the Japanese market, PMDA provides various consultation services ranging from pre-application consultation, clinical trial consultation, and application procedure consultation. Because these meetings are conducted in Japanese, translators are invaluable in providing guidance on any specific language requirements or nuances that may be relevant to the regulatory agency in question, which can help the manufacturer to present their case in the most effective way possible.

The China Food and Drug Administration (CFDA) have made landmark amendments to its imported drugs policy. Where previously, imported drugs had to be in at least in Phase II in another country before beginning clinical trials in China, the CFDA now allows manufacturers to present data from international trials that include China as a study site.

In such cases, translators are central in ensuring that clinical trials are in compliance with the local regulations and cultural norms of the target country by facilitating communication between the trial sponsor and local investigators, research staff, and especially the participants. This includes providing participants with contextualized information to allow for informed consent and decision-making, and continuing to do so throughout the duration of the study. Back translation validates whether the trial protocols and participant-facing materials communicate exactly what they are intended to relay and that meaning is preserved.

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