Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
In its review, Medsafe’s committee considered TGA’s rationale and the evidence behind the decision. The review also looked at regulatory advice from Medsafe and the Medicinal Cannabis Agency and five comments it received after announcing the topic was to be discussed at the meeting. Based on the evidence, the Medsafe committee saw too much uncertainty to recommend allowing over-the-counter sales of low-dose CBD in New Zealand.
The International Council for Harmonisation (ICH) has adopted its guideline on continuous manufacturing (CM), in a nod to embracing more modern modes of manufacturing. In the final version of guidance, ICH acceded to industry’s request to clarify ...
The European Medicines Agency (EMA) has recommended that pholcodine-containing drugs be pulled from the European market after its experts agreed there was a significant risk of allergic reaction to neuromuscular blocking agents (NMBA). The recomme...
Fewer biosimilars have been marketed in the United States, compared with Germany and Switzerland, and prices are significantly higher in the US. However, biosimilars that have been introduced in the US recently had a stronger uptake than products ...
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
Quality regulatory writing is the foundation of successful regulatory work. Regulatory professionals must communicate effectively and efficiently to convey complex concepts within tight timelines. The strength and purpose displayed ...
The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies (BE) for investigational new drugs (INDs), new drug applications (NDAs), abbreviated new drug...
The US Food and Drug Administration (FDA) on Friday revised its draft guidance on submitting pre-submission facility correspondence (PFC) for generic drug applicants seeking a priority review of their abbreviated new drug application (ANDA), prior...
The Swiss parliament has asked the country’s Federal Council to adapt its laws to allow medical devices that have been vetted by non-European regulators, such as the US Food and Drug Administration (FDA) to be marketed in Switzerland. Currently, o...
A top US Food and Drug Administration (FDA) official touted the benefits of cloud-based regulatory submissions in ensuring consistent product reviews and explained how the agency is moving towards this platform through ongoing internal and interna...
The first three studies will look at the epidemiology of rare blood cancers to understand their prevalence in Europe; the use of the teratogenic epilepsy drug valproate; and the use of antibiotics to inform future work on antimicrobial resistance....
The US Food and Drug Administration (FDA) recently warned a clinical trial sponsor for failing to submit an investigational new drug application (IND) for its drug-device combination eye treatment and failing to obtain approval from an Institution...
Key industry stakeholders have asked the US Food and Drug Administration (FDA) to pull its recently published draft guidance on laser-assisted in situ keratomileusis (LASIK) patient labeling, arguing that the agency’s recommendations are based on ...