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  • Subject area(s): Marketing
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  • Published on: 14th September 2019
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A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, and route of administration, quality, performance characteristics and intended use.  All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). The first generic applicant to file a paragraph IV certification is awarded a 180-day market exclusivity period by the USFDA.

By looking at the different regulatory environment, it is impractical to get global marketing approval at same time and launch in all the regions at one go. Hence, it is necessary to understand and define the clear regulatory strategy by looking at the target regions, different patent terms and its extension, various application possibilities, data requirements, deadlines for launching products to be marketed in different regions. This eliminates unnecessary studies, minimizes the delay in drug approvals and subsequent launch, and reduces overall cost of research and development.

Although the requirements are harmonized in regulated countries by CTD (Common technical document) filing, yet others have enormous diversity in requirements.ICH brought regulatory authorities and pharmaceutical industries of Europe, Japan and US together for various aspects of drug registration should bring some requirement to be harmonized there in emerging market, so that the drug approval process becomes easy and duplication of work and waste of valuable resources avoided. By examining these markets individually, it would be easier to target the areas where they can specifically improve their regulatory barriers, thus leading the way for the rest of the countries.

Finally, there needs to be a reassertion that the purpose of drug registration is to protect the public health, not to facilitate profit of pharmaceutical manufacturers. Registration should be seen as a critical step in ensuring access to safe and effective medicinal product


It is concluded that though the in USFDA, filing through NDA application for getting approval for new drugs and ANDA application is for getting approval for generic drugs which similar to innovative drugs in the case of dosage form, strength, and route of administration, quality, performance characteristics and intended use. CTD is the common format for filing dossiers in US, Europe and Japan. The two major pharmaceutical markets are involving in the generic Pharma field as no. of the patents are going to be expired in future. Due to this, many generic applicants are keeping busy themselves in the finding the patent claims loop holes and paragraph certification filing to achieve the market as first as possible. For this electronic version of the CTD is being used.

 Module 5: Clinical study Reports – The clinical trials and their reports carried out on the human beings to list the desired effect of the drug product are included in this section. It is to provide to the regulatory authority containing the informations which prove the efficacy of the drug. For generic drugs, the applicant only has to prove the bioavailability similar to that of innovator or branded drug only. To conduct such bioequivalence studies9 (BA-BE), healthy volunteers are selected and to be conducted in a controlled manner.

Before CTD/eCTD application for the submission of a drug application, the procedure was different as per the country wise. In US, NDA, ANDA, BLA, Integrated summary of Safety (ISS), integrated summary of Efficacy (ISE) was submitted for the approval of the product as shown in the Figure 2, so many duplicate copies were required to make according to the FDA11

Figure 7 The CTD Triangle

In European Union, the expert reports and tabulated summaries were recommended n Europe before the recommendation of CTD as shown in Figure 3. Likewise, In Japan, GAIYO format13 was followed for the filing of the regulated drug application as shown in the Figure 4.

The tables given below consist of the possible regulatory requirements for the registration application as per US and European regulatory guidelines:

Comparison between US eCTD and EU eCTD

Table 2 Comparision between US & EU  eCTD



1. FDA is the sole regulatory authority for controlling and regulating the food and drugs. 1. EMEA is the centralized authority and many CPMP, MHRA, CHMP etc. country wise for the approval of the market authorization application in whole Europe.

2. The eCTD is mandatory for the submission of the drug applications (NDA/ANDA) 2. The eCTD is not fully mandatory but NeeS is submitted along with the paper submission for MAA till end of December 2009.

3. US FDA guidance (CFR) documents and FDA sections (e.g. 505 (b) for NDA and 505(j) for ANDA) are followed for the preparationof the dossier for the drug approval applications. 3. Expert reports and Directives (e.g. Directive 2001/83/EC-Article 8(j))16 drafted are followed in making the dossiers for market authorization application.

4. The applications are different e.g. For new drug- NDA For generic drug – ANDA For biological application – BLA 4. Only single type of application is applicable for each new drug, generic drug etc is MAA (Market Authorization Application).

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