International Notifications
The countries of the world are increasingly implementing new chemical notification procedures that must be followed prior to commercialization of a new chemical. Eventually, there may be a common international notification but for the near future most countries have individualized requirements. These requirements are often based on historical national issues with toxic chemicals. For example, in Japan there is a much greater relative importance placed on biodegradation since there is a history of environmental contamination and bioconcentration associated with serious adverse effects in the population.
It is advisable to “think globally” when a commercialization and notification program are initiated. The world has become a much more open market for chemicals, drugs and medical devices. Unfortunately, due to varying specific requirements, approval in one, or even many, countries does not assure full international marketability. Notification strategies should optimally be developed prior to marketing strategies since a notification can require years to accomplish. Conducting studies according to internationally accepted protocols could save much time and money. Likewise, staging of notifications to coordinate with marketing plans could be used to maintain a positive cash flow from developing product.
ToxicSolutions is aware of international regulatory activities and can assist you with strategies or international notifications. Most notifications are done in conjunction with a collaborator inside the country or area of the proposed notification to assure conformation to the national requirements. For example, ToxicSolutions has an arrangement with Shin Won Scientific Company in Korea to facilitate Korean notifications.