How To Develop A Regulatory Strategy: An Overview

The old adage ‘failing to plan is planning to fail’ could not be any truer when considering your regulatory strategy.  A carefully crafted regulatory strategy is crucial when a pharmaceutical company wishes to market its medicinal product across regions subject to different regulatory requirements.

What Is A Quality Target Product Profile?

One of the most critical elements in developing your regulatory strategy is devising upfront a target product profile (for the US) or a Quality Target Product Profile (QTPP, for the EU). The QTTP is a document that summarizes the key goals of a drug development program and is typically used to convey information the sponsor intends to include in a product’s labelling or to detail critical manufacturing or quality attributes of a product. The International Council on Harmonization (ICH) also recommends sponsors develop a QTTP as part of its guidelines on pharmaceutical development [ICH, 2009]. The QTPP may discuss aspects such as intended use in clinical setting, route of administration, dosage form, delivery systems, dosage strengths, container closure systems along with the products manufacturing process.

As soon as the QTPP has been established, the regulatory strategy required to get the product to market can be developed. Thus the QTPP dictates key aspects of the development program, ensuring that quality is built into the product by design. Following the execution of the clinical development plan, the TPP/QTPP matures into the prescribing information in the US and into the summary of product characteristics in Europe.

Key considerations for any MAH which may shape their development programme might include:

(a) the proposed indications for the medicinal product;

(b) the age profile; filing options;

(c) data exclusivity requirements;

(d) legal basis;

(e) competitive landscape


(f) appropriate bioequivalence requirements.

We Can Help

Our team of experienced consultants has extensive practical experience in this area and can help you choose the most appropriate path to market-based on your specific circumstances.     If you would like to discuss this issue with us then please contact us on 00353 52 61 76 706 or complete your details below.  Regulatory strategy development is pivotal to the success of every pharmaceutical product and our experts can assist you in the development of your strategy.

Further Reading from Acorn Regulatory

What Are Post-Marketing Surveillance Studies?

Post-marketing surveillance studies are defined in  Article 1(15) of Directive 2001/83/EC as studies carried out after a medicine has been authorised to obtain further information on a medicine’s safety or to measure the effectiveness of risk-management measures.  In this article, our Medical Manager, Dr. Danica Cvetkovic, looks at post-marketing surveillance studies and the link with Risk Minimisation Plans (RMP’s)

Read the article here.

Understanding MDR: 8 Important Changes

The advent of the new Medical Devices Regulation (MDR 2017/745) is a cause of much concern for manufacturers and others in the devices sector.  The new regulations will bring about many changes compared to the current regulatory framework.  We look at the basics of the new MDR and the changes that will impact the device sector from May 26th, 2020. Read the full article here.

Need A WDA? Read Our Step By Step Guide

There has been significant growth in the number of companies seeking a Wholesale Distribution Authorisation (WDA) in recent years.  We have assisted many companies with every step of the process. Here, we outline a step by step guide for obtaining a WDA.  Read the full article here.

How To Prepare For A Pharmacovigilance Inspection

A pharmacovigilance inspection can be a daunting prospect for many companies.  Since 2002 we have worked with countless companies to guide them through their inspections. We look at the measures that your company can take to be prepared.  Read the full article here.

How To Complete A Type I Variation

Type I Variations to a Marketing Authorisation are surprisingly difficult.  The procedure that many people perceive to be a simple process can prove to be otherwise.  This article looks at how to complete a type 1 variation and we will consider:

  • common deficiencies
  • common validation issues
  • the challenges posed by the eAF
  • what to do when documentation is missing
  • how to handle GMP variations
  • what happens when a CEP is presented for an active substance instead of a GMP certificate

After reading this article you will be better placed to complete a Type I Variation to a Marketing Authorisation while avoiding the common pitfalls outlined below.  Read the full article here.

What Are The Initial Steps in Applying for a Marketing Authorisation?

We consistently receive questions regarding the steps required when applying for a marketing authorisation (MA).  In this article, we aim to provide a guide to assist companies applying for an MA

We have also provided a number of links throughout the article to relevant articles, authorities, organisations, and pieces of legislation to assist you.  Read the full article here.

KASA – What You Need To Know About Knowledge-Aided Assessment and Structured Application

What is KASA and how will it impact on getting a drug assessed by the US FDA?  We look at its ‘3 pillars’ and what it aims to be.  Importantly, we look at how the FDA believes it will change how drugs are assessed in the United States of America.

Read more about KASA here.

About the Author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD