Challenges of biological drug registration in VietNam and suggesting for improving registration process in a local pharmaceutical company

HO CHI MINH CITY OPEN UNIVERSITY UNIVERSITÉ LIBRE DE BRUXELLES

SOLVAY BRUSSELS SCHOOL OF

ECONOMICS & MANAGEMENT

MBQPM5

“NGUYEN NHU TRANG”

“CHALLENGES OF BIOLOGICAL DRUG

REGISTRATION IN VIETNAM AND SUGGESTING

FOR IMPROVING REGISTRATION PROCESS IN A

LOCAL PHARMACEUTICAL COMPANY”

MASTER FINAL PROJECT

MASTER IN BUSINESS QUALITY AND PERFORMANCE MANAGEMENT

Ho Chi Minh City

(2016)

HO CHI MINH CITY OPEN UNIVERSITY UNIVERSITÉ LIBRE DE BRUXELLES

SOLVAY BRUSSELS SCHOOL OF

ECONOMICS & MANAGEMENT

MBQPM5

“NGUYEN NHU TRANG”

“CHALLENGES OF BIOLOGICAL DRUG

REGISTRATION IN VIETNAM AND SUGGESTING

FOR IMPROVING REGISTRATION PROCESS IN A

LOCAL PHARMACEUTICAL COMPANY”

MASTER FINAL PROJECT

MASTER IN BUSINESS QUALITY AND PERFORMANCE MANAGEMENT

Tutor: Jacques Martin

Ho Chi Minh City

(2016)

HO CHI MINH CITY OPEN UNIVERSITY UNIVERSITÉ LIBRE DE

BRUXELLES

SOLVAY BRUSSELS SCHOOL OF

ECONOMICS & MANAGEMENT

MBQPM5

“NGUYEN NHU TRANG”

“CHALLENGES OF BIOLOGICAL DRUG

REGISTRATION IN VIETNAM AND SUGGESTING

FOR IMPROVING REGISTRATION PROCESS IN A

LOCAL PHARMACEUTICAL COMPANY”

MASTER FINAL PROJECT

MASTER IN BUSINESS QUALITY AND PERFORMANCE MANAGEMENT

Tutor: Jacques Martin

Ho Chi Minh City

(2016)

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ACKNOWLEDGEMENTS

Firstly, I would like to acknowledge the support of Prof. Jacques Martin who gave me

strength, encouragement and his kind input and re-sharpening of my ideas.

Special appreciation is also expressed to all Drs and Professors from the Master In

Business Quality And Performance Management 5 program, for their professional advice

on data collection, review and methodology that truly supporting for final report writing.

I also extend my gratitude to DAV Officers, specifically the Director of the Drug

registration Department, Mr Chu Dang Trung, for approving for me to purse the data

collection and follow – up interview, and the whole Department of Medicines Registration

for their material support during data collection.

I extend my gratitude to pharmacist in-charge and evaluators for devoting their time

cooperation given during data collection.

I specially acknowledge the HL Pharma company, the Executive Management team, and

Head of R&D department, for accepting this work to be done supported me academically

and materially during this final report preparation.

I also extend my gratitude for the moral support and assistance from my colleagues in the

MBQPM5 class during times academically.

Finally, I would like to send my deep gratitude to my family for all of their supports and

encouragements.

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ACCEPTANCE OF FINAL PROJECT REPORT FOR DEFENSE

Mr/Ms NGUYEN NHU TRANG’s final project report for the degree of Master in

Business Quality and Performance Management is officially accepted for defense.

On 14 April 2016

Dr. Jacques M.A. Martin

Academic Director

Master in Business Quality and Performance Management

Solvay Brussels School of Economics and Management – Ho Chi Minh City Open University

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TABLE OF CONTENT

1 INTRODUCTION ................................................................................................................11

1.1 BACKGROUND............................................................................................................11

1.2 PHARMACEUTICAL MANAGEMENT SYSTEM ....................................................12

1.3 HL PHARMA ................................................................................................................12

1.4 HISTORY OF REGISTRATION IN VIETNAM..........................................................13

1.5. GENERAL DESCRIPTION OF REGISTRATION PROCESSES..............................14

1.5.1 Drug regulation process...........................................................................................14

1.5.2 Key players and tasks in drug registration ..............................................................15

1.5.3 Regulatory affairs department .................................................................................15

1.6 Drug registration process in HL Pharma........................................................................16

PART 1: METHODOLOGY...................................................................................................18

Chapter 1 REGULATORY FRAMEWORK..........................................................................18

2.1 Legislative in harmonization trends...............................................................................18

2.1.1 ICH hamonization ...................................................................................................18

2.1.2 ASEAN Harmonization strategy .............................................................................19

2.1.3 ASEAN Harmonization in Vietnam........................................................................20

Chapter 2 METHODS AND MATERIALS...........................................................................21

3.1 Study Design ..................................................................................................................21

3.2 Study participants ..........................................................................................................21

3.3 Study Period...................................................................................................................21

3.4 Sampling technique........................................................................................................21

3.4.1 For identification the challenges of medicines registration process in Vietnam.....21

3.4.2 To determine the need of good registration process in HL Pharma ........................22

3.5 Data Collection...............................................................................................................22

PART 2: ANALYSIS AND REVIEW....................................................................................23

Chapter 1 RESULTS ...............................................................................................................23

4 1 Socio-demographic information of participants.............................................................23

4.2 Companies represented, and their number of biological products registered ................24

4.2.1 Companies represented............................................................................................24

4.2.2 Time taken for dossier registration approval...........................................................25

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4.2.3 Time taken for dossier registration preparation.......................................................25

4.3 Assessment of knowledge with regards to medicines registration.................................26

4.4 Practice among DAV evaluators on medicines registration ..........................................27

Chapter 2: ASSESSMENT OF CHALLENGES IN DRUG REGISTRATION

PROCESSAND REVIEW.......................................................................................................29

5.1 Challenges encountered by evaluators (21) ...................................................................29

5.2 Challenges encountered by representatives of manufacturer (40).................................31

6 REVIEW CURRENT QUALITY MANAGEMENT IN HL PHARMA............................32

6.1 GDP system in HL Pharma ............................................................................................32

6.2 Registration system in HL Pharma ................................................................................33

6.2.1 The current role of regulatory activities within HL Pharma ...................................33

6.2.2 Improve the registration process .............................................................................34

7. CONCLUSION AND RECOMMENDATIONS ................................................................38

7.1 CONCLUSION..............................................................................................................38

7.2 RECOMMENDATIONS ...............................................................................................38

REFERENCES ........................................................................................................................42

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