Read our case study and know how an advanced overview of the regulatory environment is fundamental to an efficient go-to-market strategy for disinfectant products in the Southeast Asian market.
How Advanced Overviews of the Regulatory Environment Support Efficient Go-to-market Strategies
A European MNC, which is a global leader in the FMCG industry, wanted to design their market strategy to place new disinfectant products in the Southeast Asian market. The intention of this company’s new strategy was to leverage the regulatory environments to find out the business opportunities in the home care and personal care categories,
– in the following countries:
- The Philippines Islands,
- and Myanmar.
– on disinfectant and kill-germs products:
- for skin,
- for surface (Including premises such as homes, medical areas, hospitals, and public areas such as schools),
- and for both skin and surface.
The main business goal was to address as many of the untapped markets in 1 strategic plan. The challenge was that this MNC was targeting 8% of the world’s population in this one strategic plan, encompassing 7 different languages sharing little commonality. The target countries also had different levels of maturity and sometimes lacked precise regulations in the requested scope (For example, some specific words don’t exist in some countries’ regulations, and depending on countries or claims, the products would be considered in different categories). Additionally, the target countries classified disinfectant products differently, resulting in inconsistent and complex regulatory pathways across the different countries, with some applying much stricter regulations and constraints.
What’s the challenge?
In each of the 7 countries, the objective was to:
• identify all the existing categories according to the formulations and the intentions for use
• understand each category’s requirements
• comprehend strict legislation and higher barriers to entry in some countries due to the products being classified under certain categories (A simple disinfectant product may be categorized under Drug category)
• identify which category the products may be classified under according to the existing formulations and claims
• estimate the time and cost to address the regulatory gaps
• recommend formulation and claim adaptations when necessary and design the best strategy in terms of speed and cost-efficiency; for example, identifying and applying the most commonly compliant formulation across the region.
What we did…
RegASK provided the client with a regulatory overview and go-to-market strategies for each of the seven countries that included:
• the regulatory overviews of the categories that covered the intentions of use and channels targeted.
• the formulation and labeling overviews
• the product claim mapping per classification
• the key stakeholders implicated in the regulatory pathway to product rollout
• competitor highlights
In detail, the reports delivered included comprehensive and specific regulatory insights on the following:
• The definition of each category (Medical device, Drugs, OTC, Cosmetics and Personal Care, Household/Urban hazardous substance)
• The formulation and ingredient requirements (positive and negative lists)
• The packaging label requirements
• The permitted and prohibited claims
• The mandatory or voluntary tests
• The distribution channels
• The Advertising materials (Advertising control, pre-approval)
• The registration and import requirements
What was the outcome?
RegASK provided a comprehensive review in less than 5 weeks, and the client was able to leverage RegASK’s expertise to design its strategy to distribute new products according to the competitive white spaces, and regulatory constraints and benefits in terms of classification categories, intentions for use, composition, formula, product claim, and front-of-pack labeling.
Scope of the market expansion: 7 countries, 637M potential consumers / 25 regulations / 5 product categories
RegASK is here to help you quickly find the proper regulatory insights for your products’ expansion strategy worldwide. Contact us and tell us more about your regulatory affairs needs.