Read our case study and know how an advanced review of the regulatory environment is fundamental to efficient go-to-market strategies for disinfectant products in the Southeast Asian market.
A European MNC, a global leader in the FMCG industry, wanted to design a market strategy to place new disinfectant products in the Southeast Asian market. The objective of this company’s new strategy was to leverage the regulatory environments to find business opportunities in the home care and personal care categories.
The company aimed to address as many of the untapped markets as possible in one strategic plan, targeting 8% of the world’s population across 7 countries (Singapore, Malaysia, Indonesia, Thailand, Vietnam, Philippines, and Myanmar). The challenge was that the 7 countries are at different levels of regulation maturity in the requested scope – some countries apply much stricter regulations and constraints than others, resulting in inconsistent and complex regulatory pathways.
Additionally, the classification and definition of disinfectant products differ across the target markets, creating a potential need to reformulate and change labels at extra cost.
The company engaged RegASK for its regulatory solutions that met their unique needs in each of the 7 countries:
- Identify all the existing categories according to the formulations and the intentions for use
- Understand each category’s requirements
- Comprehend strict legislation and higher entry barriers in some countries due to the products being classified under certain categories (A simple disinfectant product may be classified under the Drug category)
- Identify which category the products may belong to, based on the existing formulations and claims
- Estimate the time and cost needed to address the regulatory gaps
- Assess formulas and claims, identify common formulas that can be applied across similar cluster countries to minimize the need for reformulation and changing labels
- Recommend formulation and claims adaptations where necessary and design an optimal product strategy in terms of speed and cost-efficiency
RegASK Guidebooks provided the client with a regulatory overview and go-to-market strategies for each of the 7 countries. The Guidebooks cover all aspects of regulations from criteria for the definition of product category (Medical device, Drugs, OTC, Cosmetics and Personal Care, Household/Urban hazardous substance), formulation and ingredient requirements (positive and negative lists), packaging and label compliance, claim mapping feasibility by category, permitted and prohibited claims, safety and advertising distribution channels requirements, advertising materials (advertising control, pre-approval), mandatory or voluntary tests, to registration and import requirements.
The Guidebooks further highlight country differences, cluster countries with similar regulations, and recommend an optimal product strategy to the client. The Guidebooks are updated using the monitoring service of RegAlert which keeps the data up to date.
Additionally, RegASK conducted an overview of claims regulations enforcement from a competitor review, giving the client a deep dive into the competitive landscape.
RegASK delivered 25 Guidebooks for 7 countries in 2 weeks. The client was able to leverage RegASK’s expertise to design and optimize its path-to-market strategy, reduce the time needed for completion of registration, and enter markets with less complexity.
Moreover, RegASK’s mapping of the client’s existing formula against formulation requirements in target markets helped the client reduce the need to reformulate, allowing them to successfully launch products at a minimal cost.
RegASK is here to help you quickly find deep and unparalleled regulatory insights for your products’ expansion strategy worldwide. Contact us and tell us more about your regulatory affairs needs.
Success of the market expansion: 7 countries, 637 million potential consumers / 25 regulations / 5 product categories
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