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.
 ..

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  ..