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 and (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. [ninja_form id=1]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