Tag Archives: PIP

EMA published questions and answers on the procedure of pip compliance verification

Posted on November 12, 2011 by damienbove| Leave a comment

full text here

This question-and-answer document has been published with the goal of replacing the existing procedural advice for validation of new marketing authorisation application-extension/variation application and compliance check with an agreed PIP (paediatric investigational plan).

the compliance check is an important part of the PIP program and as a key part of the drug development program in Europe, and this document is aimed at assisting people to understand procedures.

questions include:

  • what is the purpose of this document?
  • What are the main changes in comparison with previous guidance document?
  • what are the reference documents?
  • what is compliance check
  • what is the difference Twin full and partial compliance check
  • what is paediatric validation how is it different from compliance check
  • who performs the validationand the compliance check
  • how early before submission of the regulatory application, can a compliance check be requested?
  • I am coming for a pre-submission meeting at the EMA before applying for a marketing authorisation can I discuss compliance check?
  • how do I apply for a compliance check to the PDCO?
  • I have realised that because of difficulties in the implementation, the PIP is no longer workable or appropriate, and one or more key binding elements of the PIP would not be respected. What should I do?
  • I have a PIP with one or more studies/measures deferred. What do I need to do?
  • I had not submitted the necessary documents for the compliance check, but the validation procedure for my regulatory application has determined that there is a need to perform the compliance check. What happens now?
  • How long do the validation compliance check procedures last?
  • what is the procedure of compliance and validation at NCA level?
  • What happens if the compliance check is negative?
  • What happens if, after an initially positive compliance check, subsequent assessment of my regulatory application by the competent authority concludes that the development was actually not performed in conformity with the PIP decision?
  • Are compliance outcomes published?
  • are the other obligations of marketing authorisation holders, regarding compliance with the agreed PIP?

 

→ Leave a comment

Posted in clinical

Tagged , , , ,

EMA Issues Reminders on PIP Deferral Obligations

Posted on May 25, 2011 by admin| Leave a comment

EMA Issues Reminders on PIP Deferral Obligations

Full Text Here

The European Medicines Agency reminds all marketing authorisation holders that have been granted a deferral in their agreed paediatric investigation plan (PIP) that they are obliged to submit an annual report on deferred measures.

Companies should submit their annual reports in line with the guidance on annual reports on deferrals using the template for annual report on a deferral.

The Agency can grant a deferral to a PIP when there is insufficient information to demonstrate a medicine’s effectiveness and safety in adults. A deferral allows the company developing the medicine to delay its development in children until this information is available.

The obligation to submit an annual report on deferrals is defined in Article 34(4) of the ‘Paediatric Regulation‘ (Regulation (EC) No 1901/2006). This states that the annual report should provide an update on the company’s progress with the agreed paediatric studies.

For Assistance with Paediatric Development Plans Click Here

Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!

Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.

Fill Out the Short Form Below…


  1. (required)


  3. (valid email required)

“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”

→ Leave a comment

Posted in clinical

Tagged ,

Paediatric Investigation Plans – New Regulations

Posted on October 7, 2008 by admin| 3 Comments

New regulations have come into force relating to the development of drugs for Children, and these regulations will impact on every single drug development programme currently ongoing. It is critical that you know about these regulations and how to adapt to them.

Every product must have agreed a Paediatric Investigational Plan (PIP) with the EMEA (via the PDCO – Paediatric Committee) before they register their product. In the future this will change to every product must be implementing a PIP before they can register their product.

The PIP describes the investigation that you propose to do in order to establish safety and efficacy in a paediatric population. You must put this plan together with the expectation of carrying it out. Every product must have one, it will not be acceptable to just say “children don’t get this disease” you will have to prove it.

The committee will not give a waver for any technology that can not prove that their therapy could benefit children. If there are enough Paediatric Patients to power a comparison study it will have to be undertaken.

If you would like to know more about these rules have a look at the this website.

We will be publishing more information on this in the near future.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com

→ 3 Comments

Posted in regulatory

Tagged , , ,