SE Asia’s Local Restrictions Increase Gap in Product Availability

While registering products in Southeast Asia may be less expensive in some regions of the world with shorter timelines, the diversity of each country’s government and languages, along with smallholder farmers, makes this a nuanced region for regulations.

Edward Qin Business Development Manager Staphyt

Here are three trends that Edward Qin, Business Development Manager for Staphyt is observing in 2024.

“SE Asian authorities tend to follow the EU evaluation decisions in phasing out active ingredients. Although the product layout and crop solutions in SE Asia are different to EU, SE Asian countries tend to ban molecules that have been phased out in EU.

“Vietnam and Myanmar have been most active in following EU bans. However, there are less alternative AIs in SE Asian countries to substitute banned molecules. This causes some problems in product availability in SE Asia, but also triggers the motivation of China and local companies in registering new products.”

“The trends of new product registration applications have been very positive in all SE Asian countries.

“However, compared with EU and China, the product diversity and product availability in SE Asia is relatively weak. Due to the following EU evaluation decisions, there are even fewer products available.

“Due to SE Asia’s climate and crop diversity, the complexity of solutions to target weeds, pests and diseases is complicated. Local demand encourages new products.

“In 2024, the number of applications in SE Asian countries have been increasing steadily and causing longer waiting and evaluating times before approval. Among the new applications, Chinese companies have contributed most of the products.”

“Regulations in SE Asian countries remain stable with no significant changes on the legislation level. On the operational level, it is a different story. Local authorities are tightening the restrictions of pesticide regulation.

“In the past years, the data requirement of SE Asian product registrations has been relatively simple, compared with Latin American countries. They used to accept the translated study report from China as part of the registration dossier.

“In recent years, especially in 2023-2024, local authorities are requesting all external data be submitted with GLP authentication, and to OECD guidelines, or the data shall be generated in the target country locally (e.g. field efficacy trials).

“Overall, this is a great step in SE Asian countries moving toward global harmonization in agrochemical evaluation. This trend has also triggered a boom in business for OECD GLP labs and CROs.”

Three Ls of Registering Pesticides in SE Asia

By Dr. Piyatida Pukclai Regional Sales & Regulatory Policy Manager (Asia-Pacific) knoell

In Southeast Asian countries, pesticide registration typically requires a local entity as the registration holder. This ensures a local presence to manage regulatory needs and issues. The local entity must be a registered company authorized for pesticide operations. Verification is crucial to confirm the entity’s eligibility to hold registration licenses.

Southeast Asian countries mandate local efficacy trials to validate pesticide effectiveness in local conditions. Trials are essential to demonstrate performance in specific climates, soils, and against local pests. Understanding country-specific requirements for trial protocols is vital, considering variations based on crop types

Each Southeast Asian country has its own pesticide registration laws, creating a complex regulatory landscape. Regulations differ significantly between countries, necessitating thorough understanding and compliance. Language barriers require translations and local expertise for navigating regulatory requirements. Formal written submissions are typically required for communication with regulatory authorities, often following regulatory meetings or reviews.  •

Dr. Piyatida Pukclai – Knoell
Edward Qin – Staphyt