active pharmaceutical ingredient assessment update 2015 · pdf fileactive pharmaceutical...

Active Pharmaceutical Ingredient

Assessment

Update 2015

1Copenhagen, Denmark 23-26 November 2015 - API Assessment update

API: active pharmaceutical ingredient

APIMF: active pharmaceutical ingredient master file (aka ASMF, DMF)

FPP: finished pharmaceutical product

PQT: Prequalification Team

IGDRP: International Generic Drug Regulators Programme

Acronyms


Part I: The status of API assessment

Part II: Advice to applicants

Part III: The IGDRP

Introduction


There are three procedures used in PQT related to API

information:

• API Prequalification

• APIMF Procedure

• APIMF amendment procedure (Post acceptance)

Part I: API Assessment


API Assessment

5

EDQM CEPFull Data APIMF

Procedure

Drug Master File

(APIMF)

Prequalified FPP (standard Process)

Clinical FPP API

GMP (CRO, FPP, API)

Prequalified API

GMP API

WHO List of Prequalified Medicinal Products WHO List of Prequalified APIs

PQ API

Copenhagen, Denmark 23-26 November 2015 - API Assessment update

Website – APIMF Procedure


Website – API Prequalification


Amendments


Q&A Documents


215 APIMFs accepted or under assessment

This includes:

85 Prequalified APIs and,

55 applications seeking API Prequalification

We are pleased with progress so far!

Some statistics


API Starting material selection

The API-QIS

Understanding the amendment procedure

Part II: Advice to Applicants


This guy is the probably unaware of the starting material selection

issues.

Correct selection and justification remains a problem.

Getting early advice should be considered.

API Starting material selection


This is increasingly common.

The information provided on the steps undertaken by external

intermediate suppliers should be of the same quality as those

steps undertaken by the API manufacturer.

Identifying necessary information in the APIMF can be a challenge

for assessors when dealing with external intermediate

manufacturers.

See the published Q&A document (APIMF Procedure) for

information on organisation of this information.

External Intermediate manufacturers


This is a summary document present in the assessment report and

is finalised as part of the acceptance of an APIMF.

API-QIS


The API-QIS is a very useful document for PQT. It ensures mutual

understanding of key information between PQT and the APIMF

holder.

An annotated API-QIS is requested as part of all APIMF

amendment applications, to verify the changes being proposed.

The accepted API-QIS is attached to the acceptance letter of every

amendment to ensure on-going understanding of key information.

Applicants have 7 days to raise issues on the information in the

API-QIS when they received the draft acceptance letter.

API-QIS


The conditions and documentation requirements for a given

change category are spelt out in the amendment guidance.

These requirements must be fulfilled, or an alternative chance

category chosen.

There is a specific manner in which the application forms should

be filled. Follow this. There are example applications forms on the

website.

There is specific documentation and replacement subsection that

are required to be included.

APIMF Amendments


APIMF Amendment procedure


Link

Why so pedantic? - SPEED

New amendment applications have a very high priority for

completion.

Responses to questions raised on an amendment have a lower

priority.

It is important to get it right the first time.

APIMF Amendment procedure


We have obtained additional resource to help with API

assessment.

The initial focus will be to reduce amendment assessment times.

Then to reduce assessment times new APIMFs.

Speed of assessment


20

The International Generic Drug Regulators Programme

(IGDRP)


http://igdrp.com

[email protected]

21

The International Generic Drug Regulators Programme

(IGDRP) was created in 2011 to promote collaboration and

convergence of generic drug regulators in order to address

challenges posed by increasing workloads, globalization and

complexity of scientific issues.


22

The IGDRP - membershipAgencia Nacional de Vigilancia Sanitaria (ANVISA)

China Food and Drug Administration (CFDA)

European Directorate for the Quality of Medicines and Healthcare (EDQM) (Observer)

European Union:

– European Commission - DG SANTE (EC)

– Coordination Group for Mutual Recognition and Decentralised Procedures - Human(CMDh)

– European Medicine Agencies (EMA)

Federal Commission for the Protection against Sanitary Risk (COFEPRIS)

Federal Service for Surveillance in Healthcare and Social Development

Health Canada

Health Sciences Authority (HSA)

Ministry of Food and Drug Safety (MFDS)

Ministry of Health, Labour and Welfare (MHLW)

Medicines Control Council (MCC)

Medsafe

Swissmedic

Taiwan Food and Drug Administration (TFDA)

Therapeutic Goods Administration (TGA)

U.S. Food and Drug Administration (US FDA)

World Health Organization (WHO) (Observer)


23

The IGDRP

Three working groups have been identified. These are:

• An ASMF/DMF working Group (2013)

• A Biowaivers working group (2013)

• IT business needs working group (2015)


24

ASMF/DMF Working Group

Chair and co-chair – TGA and WHO

ANVISA, COFEPRIS, EDQM, EU, HC, HSA, MCC, MFDS,

PMDA, Swissmedic, TFDA.

Objective: foster international collaboration and work sharing

in the area of evaluations for ASMFs/DMFs.


25


Initial projects:

• Survey among member of their respective ASMF/DMF procedures.

• Development of an ASMF/DMF lexicon of quality terms.

Recent projects

• Agreement on the common ASMF/DMF information fields that should be recorded at the time of submission.

• Agreement of an ASMF/DMF common quality assessment report template (M 3.2.S).

• Consideration of the criteria for when a separate ASMF/DMF should be provided. e.g different polymorph, salt…


26


Many of these documents will be soon published on the

IGDRP website.

Please understand that these are model documents. They

are not mandatory for adoption by member organisations,

but members are committed to their implementation as and

where possible.


27


The projects so far have been preliminary steps towards

information and work sharing.

NEXT Project:

Investigating the possibility of an ASMF/DMF common

database for IGDRP members.


28

Common ASMF/DMF database

Small steps….

Initially this is envisaged to contain descriptive information

describing the ASMF/DMFs held by members.

…such as, ASMF holder name, ASMF version numbers, sites,….

The ability to identify common ASMFs among members

would be significant progress.

It is the first step towards report sharing and work sharing.


29

Common ASMF/DMF database

The biggest challenge to progress is the ability to share

information between agencies.

The simplest solution is to obtain permission directly from

the APIMF holder, rather than through agency to agency

agreements.

This is the approach WHO PQT would like to take, but we

will need your support.


30

Further information

The PQ website is a good source of information, please

read.

http://www.who.int/prequal/info_applicants/API_info_applicants.htm

Or email me at:

[email protected]

Thank you
