BAN BOOK

BAN BOOK

What is the BAN book

The British Approved Names (BAN) book is the official dictionary of drug names for regulatory use in the UK. The BAN book is published  by British Pharmacopoeia publication every 5 years and supplements are published annually. British Approved Names (BAN) are Ø the nonproprietary name or generic name for an active pharmaceutical ingredient (API) for use in the UK Ø distinctive names for use with medicines in the UK Ø harmonised with the English form of the recommended international nonproprietary name (rINN) The BAN publication Each entry includes: v the official pronunciation guide v systematic name v molecular formula v molecular structure v CAS registry number v pharmacological action and/or medicinal use

World Health Organization’s (WHO’s) International Nonproprietary Names (INN) Programme

World Health Organization’s (WHO’s) International Nonproprietary Names (INN) Programme

World Health Organization’s (WHO’s) International Nonproprietary Names (INN) Programme was established with a vision to have the INN used by all stakeholders across the world as a common nomenclature for all pharmaceutical substances.

An International Nonproprietary Name (INN) identifies a pharmaceutical substance or active pharmaceutical ingredient by a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name.

The existence of an international nomenclature for pharmaceutical substances, in the form of INNs, is important for the clear identification, sale prescription and dispensing of medicines to patients, and for communication and exchange of information among health professionals and scientists worldwide.

To make INNs universally available, they are formally placed by WHO in the public domain.

Nonproprietary names are intended for use in pharmacopoeias, labeling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names,e.g. for generics. Their use is normally required by national or, as in the case of the European Community, by international legislation. As a result of ongoing collaboration, national names such as

British Approved Names (BAN), Dénominations Communes Françaises (DCF), Japanese Adopted

Names (JAN) and United States Accepted Names (USAN) are nowadays, with rare exceptions, identical to the INNs.

The selection of a new INN relies on a strict procedure. Upon receipt of an INN request form, the WHO Secretariat examines the suggested names for conformity with the general rules, for similarities with published INNs and potential conflicts with existing names, including published INNs and trademarks. A note summarizing the result of these checks is added and the request is subsequently forwarded to the INN experts for comments. Once all experts agree upon one name, the applicant is informed of the selected name.

Newly selected, proposed INNs are then published in WHO Drug Information, which indicates a deadline

for a 4-month objection period. This period is allowed for comments and/or objections to the published

names to be raised. The reasons for any objection must be stated clearly and these will be evaluated by the

experts for further action. Users are invited to refrain from using the proposed name until it becomes a recommended INN, in order to avoid confusion should the name be modified.

The final stage of the selection process is the recommended INN. Once a name has been published as a

recommended INN it will not normally be modified further and is ready for use in labeling, publications,

on drug information. It will serve to identify the active pharmaceutical substance during its lifetime

worldwide. Since the name is available in the public domain it may be used freely. However, it should not be registered as a trademark since this would prevent its use by other parties.

The INN Experts meet twice a year, usually in April and October.

The name cannot be used as an INN until the INN Secretariat completes the publication process. Normally, names are published as a pINN about 6-12 months after the meeting. There is then a 4-month public comment period. If no objections are received, the name is published as a rINN.

All names selected as proposed and recommended INNs are published in a Cumulative list, which is updated periodically. The generic names are presented in alphabetical order by Latin name. Each entry includes:

v equivalent nonproprietary names: : in Latin, English, French, Spanish, Arabic, Chinese and Russian, as well as reference to other common names;

v a reference to the INN list in which the name was originally proposed or recommended, or last amended;

v reference to names of substances that have been abandoned or never been marketed;

v  reference to national nonproprietary names;

v  reference to pharmacopeial monographs or similar official references;

v  reference to names issued by the International Organization for Standardization (ISO);

v  reference to the Convention of Psychotropic Substances, if applicable;

v  reference to the List of Narcotic Drugs under International Control, if applicable;

v  the molecular formula; its Chemical Abstracts Service (CAS) number.

FDA’s Priority Review Voucher System (PRVs)

 

FDA’s Priority Review Voucher System (PRVs)

USFDA’s priority review voucher program is an expedite review scheme that grants a voucher for priority review to a drug developer as an incentive to develop treatments for drugs that might otherwise not be profitable to develop because of a smaller pool of patients needing treatment.

FDAs PRV program designed to encourage development of new drug and biological products. Priority-review vouchers are awarded to a firm that that gains approval for a designated tropical disease, a material threat medical countermeasure, or a designated rare pediatric disease.

Quick Facts About Priority Review Vouchers

Priority review voucher program was first introduced by USFDA in 2007

There are three types of priority review voucher program 1. Treatments for Tropical diseases 2. Treatment for rare pediatric disease and 3.Medical countermeasure priority review vouchers.

The sponsor who receives a priority review voucher from FDA may transfer the voucher to another sponsor. (The statute does not limit the number of times a priority review   voucher may be transferred before the voucher is used).

Transfer of priority review voucher should be documented with a letter of transfer from the sponsor who has awarded the voucher and a letter from the new voucher owner acknowledging the transfer. A voucher cannot be redeemed unless a complete record of transfer is made available to the FDA.

The price of the Voucher depends  on supply and demand

Priority review vouchers do not expire (Voucher may be kept until needed or sold)

Voucher reduces review time of an application by USFDA from 10 months to 6 months.

At least 90 days before submission of the human drug application, for which the priority review voucher will be used, the sponsor planning to use the voucher must notify the FDA of intent to use the voucher and the date on which the sponsor intends to submit the application.

When using the voucher, a sponsor must pay an extra user fee (i.e., a separate priority review user fee) to support the review of the application based on the average cost of a priority new drug application/biologics license application (NDA/BLA) review in the previous fiscal year. Payment of this extra fee, to which the sponsor is legally committed as a result of the notification of its intent to use the voucher, is not subject to waivers, exemptions, reductions, or refunds.

Priority review voucher have an identification number, which should be referred to when redeeming the voucher.

Following diseases are considered tropical diseases for priority review voucher purposes.

ØTuberculosis	Ø Malaria	Ø Blinding trachoma
Ø Buruli Ulcer	Ø Cholera	Ø Dengue/Dengue haemorrhagic fever
Ø Dracunculiasis (guinea-worm disease)	Ø Fascioliasis	Ø Human African trypanosomiasis
Ø Leishmaniasis	Ø Leprosy	Ø Lymphatic filariasis
Ø Onchocerciasis	Ø Schistosomiasis	Ø Soil transmitted helminthiasis
Ø Yaws	Ø Filovirus Diseases	Ø Zika Virus Disease
Ø Any other infectious disease for which there is no significant market in developed nations and that disproportionately affects poor and marginalized populations, designated by order of the Secretary.

Patents & exclusivity of Drug Products in US Market

Patents & Exclusivity of Drug Products in US Market

Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. In other words exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to new drug application (NDA) or abbreviated new drug application holder if statutory requirements are met. Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.

Patent terms are set by statute.  Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States.  Many other factors can affect the duration of a patent.

Patents and exclusivity apply to drugs in different ways.  Patents can be issued or expire at any time regardless of the drug’s approval status.  Exclusivity attaches upon approval of a drug product if the statutory requirements are met.  Some drugs have both patent and exclusivity protection while others has just one or neither.  Patents and exclusivity may or may not run concurrently and may or may not cover the same aspects of the drug product.

Type of Exclusivity	Tenure
Orphan Drug Exclusivity (ODE)	7 years
New Chemical Entity Exclusivity (NCE)	5 years
Generating Antibiotic Incentives Now (GAIN) Exclusivity	5 years added to certain exclusivities
New Clinical Investigation Exclusivity	3 years
Pediatric Exclusivity (PED)	6 months added to existing Patents/Exclusivity
Patent Challenge (PC)	180 days (this exclusivity is for ANDAs only)
Competitive Generic Therapy (CGT)	180 days (this exclusivity is for ANDAs only)

Prioritization of the Review of Original ANDAs, Amendments, and Supplements

 

Click to the below link to know, how  ANDAs, ANDA amendments and ANDA supplements will be prioritized for review by USFDA.

Pharma Treasures: GDUFA II Goals For ANDA Reviews: GUDFA –II Goals for ANDA Reviews   The GDUFA II (fiscal years 2018-2022) commitment letter describes a consolidate...

GDUFA II Goals For ANDA Reviews

GUDFA –II Goals for ANDA Reviews

 

The GDUFA II (fiscal years 2018-2022) commitment letter describes a consolidated review scheme for all cohorts of abbreviated new drug applications (ANDAs).USFDA targets to review ANDA applications as detailed below. 

Submission Type	Goal
Original ANDAs
Standard Original ANDAs	90% within 10 months of submission date.
Priority Original ANDAs	Within 8 months, provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j) Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and The information remains unchanged relative to the date of the submission of the application
	Within 10 months of submission date if: The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria. The applicant does not pre-submit facility information, or the facility information changes or is found to be incomplete or inaccurate.
ANDA Amendments
Standard Major ANDA Amendments	Within 8 months of submission date if preapproval inspection not required.
	Within 10 months of submission date if preapproval inspection required.
Priority Major ANDA Amendments	Within 6 months of submission date if preapproval inspection not required.
	Within 8 months, provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j) Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and The information remains unchanged relative to the date of the submission of the application
	Within 10 months of submission date if: The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria. When preapproval inspection is required, the applicant does not pre-submit facility information, or the facility information contained in the PFC changes or is found to be incomplete or inaccurate.
Standard and Priority Minor ANDA Amendments	Within 3 months of submission date.
Prior Approval Supplements
Standard PASs	Within 6 months of submission date if preapproval inspection not required.
	Within 10 months of submission date if preapproval inspection required.
Priority PASs	Within 4 months of submission date if preapproval inspection not required.
	Within 8 months, provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j) Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and The information remains unchanged relative to the date of the submission of the application.
	Within 10 months of submission date if: The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria. When preapproval inspection is required, the applicant does not pre-submit facility information, or the facility information contained in the PFC changes or is found to be incomplete or inaccurate.
Prior Approval Supplements Amendments
Standard PAS Major Amendments	Within 6 months of submission date if preapproval inspection not required.
	Within 10 months of submission date if preapproval inspection required.
Priority PAS Amendments	Within 4 months of submission date if preapproval inspection not required.
	Within 8 months, provided the applicant, not later than 60 days prior to the submission of an application, provides as required by 21 U.S.C. 355(j) Complete and accurate information regarding facilities involved in manufacturing processes and testing of the drug that is the subject of the application; and The information remains unchanged relative to the date of the submission of the application.
	Within 10 months of submission date if: The applicant does not identify the submission as eligible for prioritization pursuant to FDA’s prioritization criteria, or FDA determines it does not appear to meet the prioritization criteria. When preapproval inspection is required, the applicant does not pre-submit facility information, or the facility information contained in the PFC changes or is found to be incomplete or inaccurate.
Standard and Priority Minor PAS Amendments	Within 3 months of submission date.

Criteria for Priority Review

1. Submissions containing certain patent certifications and exclusivity statements

• Submissions for drug products for which there are not more than three approved drug products listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”) and for which there are no blocking patents or exclusivities listed for the reference listed drug (RLD) may receive a priority review.
• Submissions that contain a paragraph IV certification but become eligible for approval during the review period as a result of no blocking patents or exclusivities (including 180-day exclusivity under section 505(j)(5)(B) of the FD&C Act (180-day exclusivity)) and no applicable stays may receive a priority review if no other generic version of the same RLD has been brought to market under an approved ANDA. The absence of any blocking patent, exclusivity period, or stay must be appropriately documented in order for a priority review to be granted. For 180-day exclusivity, “no exclusivity” means that the 180-day exclusivity has either been relinquished or waived or that FDA has determined that a forfeiture of the exclusivity has occurred.
• Submissions that contain a paragraph IV certification, are submitted on the first day that any valid paragraph IV application for the drug in question is submitted, and are received as substantially complete (i.e., submissions that have “first filer” status) may receive a priority review.
• Submissions for drug products blocked by 180-day exclusivity that have been tentatively approved or submissions for drug products blocked by 180-day exclusivity that OGD determines will likely be ready for approval upon or shortly after expiration of the 180-day exclusivity may receive a priority review when such exclusivity is triggered.

2. Submissions related to drug shortages

Submissions that could help mitigate or resolve a drug shortage and prevent future shortages, including submissions related to products that are listed on FDA’s Current Drug Shortages Index at the time of the submission, may receive a priority review.

3. Submissions that are subject to special review programs such as the President’s Emergency Plan for AIDS Relief

Submissions in this category may receive a priority review.

4. Submissions related to public health emergencies

Submissions that either could help address a public health emergency declared by the Secretary of the U.S. Department of Health and Human Services, or anticipated under the same criteria as apply to such a declaration, may receive a priority review.

5. Submissions related to certain government purchasing programs

 Submissions related to certain government purchasing or procurement activities, including expiration-date extensions or packaging changes usually requested by the Government-Wide Quality Assurance Program, may receive a priority review.

6. Submissions subject to statutory mandates or other legal requirements

Submissions that are subject to federal or state mandates or other legal or regulatory actions may receive a priority review as necessary to comply with those requirements. Note: This category includes legally required changes in formulation or labeling. However, supplements submitted following actions taken by FDA field staff against applicants who put changes into effect that are required to have approved supplements under 21 CFR 314.70 will not be considered for a priority review.

7. Supplements for which a priority review is requested under 21 CFR 314.70(b)

Under 21 CFR 314.70(b), an applicant may ask FDA to grant a priority review to “a supplement for public health reasons or if a delay in making the change described in [the supplement] would impose an extraordinary hardship on the applicant.” For priority reviews, “extraordinary hardship on the applicant” will be interpreted to include the following:

i.             Catastrophic events such as explosion, fire, or storm damage to manufacturing facilities.

ii.            Events that could not have been reasonably foreseen by the applicant and for which the applicant could not have planned. Examples include:

1. An abrupt discontinuation of the supply of an active ingredient, packaging material, or container closure system.

2. The relocation of a facility or a change in an existing facility because of a catastrophic event. (In the absence of a catastrophic event, the applicant should contact OGD early in the planning stage of a contemplated relocation or change.)

8. Submissions for “sole source” drug products

 Submissions for drug products for which there is only one approved drug product listed in the Prescription Drug Product List (i.e., the “active section”) of the Orange Book and for which there are no blocking patents or exclusivities may receive a priority review, except when the approved drug product was approved pursuant to a suitability petition under section 505(j)( C) of the FD&C Act.

If approval of a submission either is dependent on the expiration of a patent (i.e., the submission contains a paragraph III certification) or is dependent on the expiration of an exclusivity period, OGD and OPQ will seek to complete the review of the submission in a manner that would permit approval by the last applicable patent expiration date or exclusivity date. However, with regard to ANDAs submitted on or after October 1, 2014:

i.             ANDAs submitted within 1 year of the last applicable patent expiration date or exclusivity date will not be considered for priority review, and FDA can provide no assurances that the review will be completed in a manner that would permit approval by the last applicable patent expiration date or exclusivity date. However, this provision may be subject to an exception when it is determined that the submission should be granted a priority review to address a public health concern. These determinations will be made by the OGD regulatory project manager (RPM) and OGD management in consultation with other FDA personnel as necessary.

ii.            ANDAs submitted more than 30 months in advance of the last applicable patent expiration date or exclusivity date will not be considered for a priority review.

FDA will only consider a priority request when (1) the submission and cover letter clearly state “Priority Review Requested” and reference the ANDA number (when applicable), (2) the basis for the request is consistent with FDAs prioritization procedure, (3) the applicant clearly and briefly states the basis of the request, and (4) the applicant includes sufficient supporting documentation for the request.

DEFINITIONS

Expedited Review: FDA will strive to act on an ANDA as soon as possible, including prior to the goal date if possible. An expedited review, though, does not result in a shorter goal date.

Priority Review: FDA will either (1) give a shorter goal date or (2) grant an expedited review.

Shorter Goal Date: In accordance with the GDUFA II Commitment Letter, FDA commits to one of the following (1) for original ANDAs, an 8-month goal date; (2) for major amendments, a 6- or 8-month goal date; or (3) for prior approval supplements, a 4- or 8-month goal date.