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.
The site navigation utilizes arrow, enter, escape, and space bar key commands. Left and right arrows move across top level links and expand / close menus in sub levels. Up and Down arrows will open main level menus and toggle through sub tier links. Enter and space open menus and escape closes them as well. Tab will move on to the next part of the site rather than go through menu items.
The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
With contributions from more than 30 authors from seven countries, the new edition incorporates a global overview of the field and is designed to help you get the most out of your regulatory intelligence endeavors.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 12 March 2015 | By Michael Mezher
The European Medicines Agency (EMA) has updated its guideline on the requirements for clinical and non-clinical development of biosimilar insulin products. The update expands the scope of the original document and gives additional detail on study design parameters.
EMA recently finalized its guideline on “similar biological medicinal products”—commonly referred to as biosimilars—which will enter into effect in April 2015. Biosimilars are products that are similar to an already authorized biological product, and can be considered equal to their reference product in terms of safety, efficacy, quality and biological activity.
Regulators have had to take a different approach to regulating biosimilars than for traditional generic drugs. Unlike chemically derived drugs, the complex biological processes involved in the production of biologicals makes them nearly impossible to exactly replicate. As such, EMA evaluates biosimilars based on a comparability assessment to their reference product.
The new Guideline on non-clinical and clinical development of similar biological medicinal products containing recombinant human insulin and insulin analogues expands the scope of the previous guideline to include intermediate- and long-acting insulin preparations, and provides more detail on study design and safety study requirements.
The guideline says that in general, “safety studies should be performed with specific focus on immunogenicity … and include a reasonable number of patients with type 1 diabetes.”
However, in certain circumstances, the safety study requirement may be waived. To waive the safety study requirement a company must demonstrate similarity between the biosimilar and its reference insulin product in “the physicochemical and functional characterization and comparison … and from the comparison of the pharmacokinetic and pharmacodynamic profiles,” and ensure there are no concerns related to the impurity profile or excipients of the product.
The guideline states that biosimilarity will be measured, “based on the physicochemical and functional characterization, the pharmacokinetic and, where needed, pharmacodynamics profiles and absence of safety issues with subcutaneous use will allow extrapolation to intravenous use, if applicable, and to other indications and patient populations licensed for the reference product.”
EMA has also published the comments it received during the consultation period for the guideline.
EMA Guideline, Overview of Comments
Tags: Biosimilars, guideline, human insulin
Regulatory Focus newsletters
All the biggest regulatory news and happenings.