What are the roles of Regulatory affairs (dossier) professionals?
Regulatory affairs professionals are the link between pharmaceutical industries and world wide regulatory agencies. They are required to be well versed in the laws, regulations, guidelines and guidance of the regulatory agencies.
As the pharmaceutical industries throughout the world are moving ahead towards becoming more and more competitive, these are realizing that the real battle of survival lies in executing the work by understanding the guidelines related to various
activities carried out to give an assurance that the process is under regulation. Pharmaceutical Industry, being one of the highly regulated industries, is in immense need of people than ever before who are capable of handling issues related to regulatory affairs in a comprehensive manner.
What is the use of Drug registration Guidelines for application for registration of drugs?
Drug registration implements one of the legal requirements for marketing of medicinal products in country. MOH prohibits the sale, offer or supply of unregistered drugs. The Act also prescribes that drugs shall only be registered if they are in the public interest, meet appropriate standards of safety, efficacy and quality and are manufactured in facilities which comply with GMP requirements.
Drug registration guidelines provide guidance to applicants who may wish to market their pharmaceutical products in the market. They intend to assist applicants in the preparation of acceptable application documents.
It is therefore essential that every person who intends to market a medicinal product in country reads the whole of these guidelines carefully and follows strictly the instructions prescribed herein. Submission of applications, which do not comply with the prescribed requirements, may result in delays, queries or rejection of registration.
What is ASEAN CTD?
The ASEAN (Association of Southeastern Asian Nations) have observed this and are now drafting the ASEAN CTD, a standard derived from the CTD. In place of the 5 modules, the ACTD organized the submission into 4 parts. This is done because ASEAN members usually only receive reference applications -- applications to put a drug on the local market that has already been approved elsewhere. As a result, the need for detailed documentation is lessened -- most study reports are not required to be submitted.
Module 1 in the CTD (the regional and registration information) is still present as Part I in the ACTD. ICH M2 is dropped and the summaries are absorbed into the subsequence parts. Quality information (ICH M3) is Part II of the ACTD, Nonclinical (ICH M4) is Part III, and Clinical (ICH M5) is Part IV.
What is a pharmaceutical regulatory affair?
Pharmaceutical Regulatory affairs is a vast area, which cannot be taught just with the help of books or the course materials. The issues related to the field are often updated so the professionals find it challenging to keep abreast with the recent modifications and inclusions.
Who is MOH (ministry of Health) or Regulatory body?
Regulatory bodies such as the Food and Drugs Administration (FDA),USA / DCGI, India are responsible for approving whether a drug can proceed to clinical trials and whether it should be allowed on the market. The regulatory body has to evaluate the scientific and clinical data to ensure that the drug can be produced with consistently high purity, that it has the clinical effect claimed, and that it does not have unaccepted side effects. It must also approve the labelling of the drug and the directions for its use. In general, the regulatory body is interested in all aspects of a drug once it has been identified as a potential useful medicine.
