Acorn Regulatory’s pharmaceutical regulatory affairs consultants are experts in the sector. Every day our team members are working on behalf of clients to ensure that their variations are completed in as timely a manner as possible. Members of our team have written extensively on this website and in other industry publications about the issues associated with variations and much more. Below we have highlighted just five articles that our team members have written on the subject in recent times. here. here.
In this article, we look at the issue of the Repeat Use Procedure. We give an overview and consider some of the issues that need to be addressed during the process. Read more here.
EMA suggest differently. Statistical data released by the EMA has revealed that 44% of all Type I variation applications received for assessment by the EMA contain errors. It is reasonable to assume that these figures are mirrored for National Procedures and Mutually Recognised Procedure variations. The figure of 44% is quite high when you consider that the variations classification guideline for Type I variations is quite detailed. The pharmaceutical industry is always pursuing initiatives to achieve “perfection” in our processes. This lean approach increases efficiency, improves quality, and achieves what the Pharmaceutical industry is primarily focused on, providing safe and effective medicinal products to the public. The function of Regulatory Affairs is no different. Identifying areas of improvement and increasing “Right First Time” is a goal of all regulatory personnel. This article details the common deficiency areas with the idea of promoting awareness. Read more here.
Decentralised Procedure (DCP) or a Mutually Recognised Product (MRP) process is drawing to a close, much of the emphasis is placed on getting a “positive opinion”. However, it is at a time like this, when submitting the final sequences that the focus on what comes next often gets lost. Frequently, companies close out their regulatory procedures only to be ill-prepared for the national phases and the product launch. What preparatory work should be done upfront to avoid this? We look at the issue and answer 10 of the most common questions relating to a DCP close-out. We hope that they will be useful to you in moving to a product launch. Read the full article here.
If you require assistance on an issue related to a Marketing Authorisation, get in touch with us on 00353 52 61 76