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.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
Keep the sparks coming! Delegates of the conference have access to on-demand content until the end of October 2021.
This updated edition is a great reference for anyone working in multinational product development and marketing.
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 01 July 2013 | By Alexander Gaffney, RAC,
The European Union is as of today one nation larger, with Croatia bringing its citizens into the union-and with them new responsibilities for companies marketing pharmaceutical products in the EU.
In July 2013, the European Medicines Agency (EMA) issued an advanced warning to pharmaceutical companies that Croatia would be joining the EU as of 1 June 2013, requiring all labeling for medications to be translated and submitted to Croatia's regulatory authorities.
"This process enables the Croatian authorities to review product information in Croatian in advance of the country's accession," EMA explained at the time. "Its aim is to facilitate the phasing-in of Commission decisions related to the EU centralised procedure and to avoid delays of supply of relevant medicinal products in Croatia after EU enlargement."
The pace of reviews at the time was described slow, but EMA had said that "no extension of the pre-accession linguistic review process (PALC III) will be granted" and "cannot be extended."
"Any product that does not go through the PALC III process will be handled after Croatia's accession in the normal linguistic review process. This means that the Croatian national competent authority will need more time for the linguistic check, resulting in delays in the decision-making process for the product as a whole," noted EMA.
In a subsequent statement in March 2013, EMA provided industry with a 40-day warning regarding Croatia's ascension to EU Member State status, issuing a practical guidance document on translating labeling into the language of a Member State. Pharmaceutical companies already had to meet the language requirements of 23 countries prior to Croatia joining the EU.
Now the day of reckoning for EU pharmaceutical companies has arrived, with EMA confirming that Croatia is officially a part of the EU, and that its representatives "will be fully involved in the activities of the seven Scientific Committees of the European Medicines Agency (EMA) as well as the Agency's other activities."
From this point forward, all pharmaceutical companies will need to have translated labeling available in Croatian for new products approved through the centralised procedure.
EMA: Croatia becomes a new member of the European medicines network
Tags: Croatia, EU
Regulatory Focus newsletters
All the biggest regulatory news and happenings.