Managing Local Language Regulatory Submissions
By Nancy Pollini
Article in PharmaExec Magazine
Few regulatory affairs heads would dispute the rising complexity of compliance and regulation in life sciences. Despite efforts to encourage consistency in international submissions, evolving priorities and variances in individual market demands are heaping the pressure on regulatory professionals. This also renders the job of translating regulatory content difficult and costly, because what works for one country or region cannot be assumed to apply in another. Requirements about which parts of a registration dossier require translation are often the subject of review.
Yet none of this must slow down the process of getting products to market. The call to reduce market entry times for life-saving new drug therapies is becoming louder and more urgent. Given such challenges, what constitutes best practice in managing translations in today’s regulatory affairs environment?