Takeda commits to registering new products in poorer countries in 12 months
Proactive preparation of new product dossiers in parallel for major markets and priority countries to facilitate faster registration.
To shorten the time taken to file to register its products.
Newly launched products can take years to be registered in less wealthy countries. Yet this is a crucial first step to making new products available.
The registration of newly launched products typically occurs less commonly in lower-income countries than in higher-income countries ones with larger markets. Yet, without a product being registered for sale in a country, it cannot be made available to the people who live there. This can adversely affect the health of people who need new products the most. Conversely, if a company commits to filing to register new products as soon as possible, this can accelerate the rate at which people get the medicines they need.
How does Takeda's registration commitment compare to peers?
The Index examines whether companies commit to filing to register recently launched products in countries in scope of the Index within 12 months of the first global product launch. Companies including Johnson & Johnson and Pfizer are participating in the World Health Organization’s collaborative procedure to help expedite the registration of some of their products in some countries in scope of the Index. However, Takeda’s overall commitment to filing to register new products is the strongest of all companies examined. It commits to prioritising and expediting the registration filings of all future products in all countries in scope in parallel to the first global market launch.
Expedited registration in Takeda’s case involves working proactively to prepare new product dossiers in parallel with dossiers for major markets. To enable this parallel filing strategy, Takeda has incorporated local and regional registration requirements for emerging markets into global development plans, and works to address those requirements earlier in the development of new drugs.
What makes this a best practice?
Takeda is the only company to make an explicit commitment via the Index to partake in the parallel registration of new products. It strives to shorten the time taken to file to register its products, with the potential to achieve registration within 12 months or less, wherever possible. These products include a dengue vaccine, which is in Phase III, a norovirus vaccine for diarrhoeal diseases in Phase II and a Phase II anti-malarial in collaboration with Global Health Innovative Technology Fund and Medicines for Malaria Venture.
The new initiative, launched in 2018, is part of Takeda’s global strategy. Working with key partners such as local health authorities and the WHO, it aims to achieve approval for all countries, including Index countries, in parallel to approval in the first major regulatory approval (for example, the USFDA or the EMA). If implemented, Takeda’s commitment would help populations in countries in scope to benefit from faster access.