- What is Drug Registration ?
Once a product has been given authorization for Marketing or free distribution and Entitlement such as first- track procedures, etc.
- · What are Regulations / Directives?
Regulations / Directives are a form of law, sometimes referred to as subordinate legislation, which define the application and enforcement of legislation. Regulations / Directives are made under the authority of an Act, called an Enabling Act. Regulations / Directives are enacted by the body to whom the authority to make Regulations /Directives has been delegated in the Enabling Act, such as the Governor in Council or a minister, etc.Regulations are USFDA terminology. Directives are EMEA / EDQM terminology.
Guidelines are departmental documents that are used to interpret legislation and/or regulation. Although they may be derived from legislation and are often used to advise how one might comply with a regulation, guidelines do not have the force of law.
- · What is Marketing Authorization ?
Official document issued by the competent Drug Registration Authorities for the purpose of marketing of a product after evaluation for Quality, Safety and Efficacy.
Interpret the data and determine if the product has acceptable Quality, Safety and Efficacy.
- · What is the reason behind change the name of EDQM as EDQM & Health Care ?
European Directorate for the Quality of Medicines (EDQM) was extended to cover two more new areas, i.e., organic transplantation and blood transfusion. So the EDQM & Health Care was started from 14.12.2006 onwards.
- · How many types of E-DMFs are in place ?
Type A New Active Substances
Type B Existing Active Substances not included in the EP or Pharmacopoeia of an EU Member State.
Type C Pharmacopoeial Active Substances included in the EP or Pharmacopoeia of an EU Member State.
DMF holders should update their DMFs for every five years (Quinquennial Update).
- · How many types of USDMFs are in place ?
Type I : Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer available)
Type II : Drug Substance, Intermediate, and Material used in their preparation or Drug Product
Type III : Packaging Material
Type IV : Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V : FDA Accepted Reference Information
DMF holders should update their DMFs annually (Annual Update). FDA is in the process of sending Overdue
Notification Letters (ONLs) to DMF holders that have not been updated, i.e., no amendments or annual reports in three years. If a DMF holder does not respond to this letter within 90 days, the DMF is retired and is unavailable for review. U.S. standard paper size (8-1/2 by 11 inches) is preferred for USDMF.
Some DMFs may be listed as inactive which are, in fact, still active. Every effort will be made to correct any errors.
The following types of DMFs may be filed as Type V DMFs without requesting prior clearance from FDA :
Manufacturing Site, Facilities, Operating Procedures, and Personnel for sterile manufacturing plants.Contract Facilities for the manufacture of biotech products.
- · How many types of Canadian DMFs are in place ?
Type I : Active Pharmaceutical Ingredients
Type II : Packaging Materials
Type III : Colourants, Flavours, and Other additives
Type IV : Drug Products.
DMF holders should update their DMFs bi-annually (Biannual Update).
- · How many types of applications for a new Certificate of Suitability
The following types of application are there for new COS :
Chemical / Chemical and Sterile / TSE / Double (Chemical and TSE) / Double and Sterile / Herbal.
- What is the criteria for fixation of unknown impurity limit in API ?
As per ICH Q3A,
If maximum Daily Dose is < 2 g / day - Unknown Impurity is 0.10%
Reporting Threshold is 0.05%
Identification Threshold is 0.10% or 1.0 mg per day intake (whichever is lower)
Qualification Threshold is 0.15% or 1.0 mg per day intake (whichever is lower)
If maximum Daily Dose is > 2 g / day - Unknown Impurity is 0.05%
Reporting Threshold is 0.03%
Identification Threshold is 0.05%
Qualification Threshold is 0.05%
- · What is DCP and What is MRP ?
DCP and MRP’s are EU registration procedures.
Mutual Recognition Procedure is European review procedure for products with an existing Marketing Authorizations.
Only possible, if authorization has already been granted.
Decentralized Procedure is alternative review procedure. Only possible, if no authorization has already been granted.
Procedure will be done among
RMS à Reference Member State
CMS à Concerned Member State
MAH à Marketing Authorization Holder
What is USFDA Form 2656 ?
It is Registration of Drug Establishment / Labeler Code Assignment. It is related to NDC Numbering.
- · What is USFDA Form 2657 ?
It is Drug Product Listing Form. It is For NDC Number.
- · What is USFDA Form 482 ?
It is USFDA inspection intimation form. [21 working days is general intimation period]
- · What is USFDA Form 483 ?
Form 483 is form to furnish USFDA inspectional observations.
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