Product registration: Which markets do pharmaceutical companies target?
A product can only be marketed in a country once it is registered for sale. Which means pharmaceutical companies must apply for registration as rapidly as possible – particularly if a product is innovative or superior to those already on the market – in order to quickly make it widely accessible for people living in low- and middle-income countries.
Registration is the first step in making a product available. It can also enable the improved collection of global epidemiological data, increase global market size and improve market competition.
The Access to Medicine Index looks for companies to file new products for registration widely and rapidly across low- and middle-income countries, starting where the need for that specific product is greatest.
What are the challenges and opportunities?
Challenges for registering new products
- National regulatory systems in need of significant capacity building
- Local regulatory requirements are complex or strict (e.g., local clinical trials and a need for originator product dossiers)
- Poor healthcare infrastructure
- Low volume markets
- Generic equivalents already on the market
- Political instability or conflict
- Economic sanctions
Opportunities to encourage registration
- WHO Collaborative Registration Procedure: Expedites registration by supporting multiple regulatory authorities.
- WHO Prequalification: An alternative route for medicines procured through the UN system for selected diseases.
- Article 58 (EMA): Assists regulatory authorities with standard scientific assessments of dossiers.
- Parallel regulatory submissions: Companies submit dossiers to both stringent regulatory authorities and health authorities simultaneously.
Which countries urgently need the most products to be registered?
The Index has identified 75 low- and middle-income countries where greater access to certain products are needed, referred to as ‘priority countries’. These countries are illustrated in the map below. The darker the country, the more diseases have been identified as being of particular concern to people living there.
Figure: Priority countries with a greater need for access to products
Per disease, an average of 13 countries have been designated as priority countries. For some diseases, including chikungunya and Buruli ulcer there are upwards of 30 priority countries.
Priority countries are defined by the Access to Medicine Index for each disease in the scope of the Index. The Index uses these lists to indicate countries with a greater need for improved access to products, per disease, based on data from WHO or the Institute for Health Metrics and Evaluation, adjusted for multi-dimensional inequality, or based on World Bank classification as a low-income country.
Over 40% of priority countries lack registration filings
Of the 75 countries identified as a priority country by the Index, 32 of these countries have so far received no registration filings for much-needed products.
Figure: Proportion of priority countries with at least one registration filing
More products are filed for registration in countries with growing populations and economies
The priority countries with the most registration filings are India, Brazil, Indonesia, China and Nigeria. Most products are filed for registration in countries with growing populations and economies. Poorer populations generally have fewer registration filings.
Figure: Priority countries with the most registration filings
Which products are filed most widely?
The disease with the most new products filed for registration is diabetes, with 142 filings. However, the most widely registered new product is Sanofi’s Hexaxim® vaccine. This vaccines is used to prevent against diphtheria, tetanus, pertussis, hep B, poliomyelitis and Haemophilus influenzae type b.
Figure: The diseases with the most new products filed for registration