AFT Orphan Blog

Every company with a commercialized Orphan Drug has gone through the blood, sweat and tears required to register their product in either the US or EU. If that first registration was gained in the EU then every effort will be made to ensure introduction in the US as soon as possible - these two markets are the key global commercial opportunities. They also offer secure supply chains and predictable pharmaco-vigilance (PV) reporting in a way that ensures the minimum amount of risk is created through commercial activities.
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Standard regulatory factors also need to be taken into account when formulating the overall Asia Pacific regulatory strategy. Some countries have relatively low governmental fees (e.g. Vietnam) whilst others are expensive (e.g. Taiwan and China) and this needs to be put into context of  ..

The five main barriers for Orphan Drugs in Asia Pacific are (1) Market complexity (2) Regulatory strategy (3) Pharmaco-vigilance (4) Ethical marketing and (5) Access to skilled regional management. This article focuses on the area of regulatory strategy. ..

The five main barriers for Orphan Drugs in Asia Pacific are (1) Market complexity (2) Regulatory strategy (3) Pharmaco-vigilance concerns (4) Ethical marketing and (5) Access to skilled regional management. This article focuses on the first ..

China is changing its attitude to Orphan Drugs – what used to be a barren waste land could become the next major Orphan Drug opportunity.
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Expanding patient access for Orphan Drugs in Asia Pacific - vast differences in patient access to Orphan Drugs exist around the world and unfortunately Asia Pacific stands out for all the wrong reasons – there is a clear lack of access to these life changing medicines. For companies with commercialized orphans the patient opportunity is vast but the barriers they encounter can appear overwhelming. ..