Myanmar Regulatory and Market Profile

REGULATORY AND MARKET PROFILE OF MYANMAR
MAAZ AHMED KHAN

BUSINESS DEVELOPMENT EXECUTIVE TRAINEE
PROSPECTS
EASY HIGH
NCA
TRADE GROWTH
ROUTES RATE
DEMOGRAPHY
SL. No Parameter Description
1 Region ASEAN
2 Country Myanmar
3 Capital Yangon
4 Population 55,622,506 (July 2018 est.)
5 Population growth rate % 0.89% (2018 est.)
6 GDP (purchasing power parity) $ 329.8 billion (2017 est.)
7 GDP - real growth rate % 6.8% (2017 est.)
8 GDP - per capita (PPP) $6,300 (2017 est.)
10 Population below poverty line 25.6% (2016 est)
11 Age structure % 0-14 years: 26.56%
15-24 years: 17.51%
25-54 years: 43.51%
55-64 years: 7.75%
65 years $ above:5.67%
Source: CIA World Fact Book updated to July 2018

QUICK STATS & PROSPECTS
• PHARMACEUTICAL MARKET SIZE: 456 Million $
• PHARMACEUTICAL IMPORT: 349 Million $(2017)
511 Million $(2022)
• ANNUAL PHARM. IMPORT GROWTH T RATE: 7.9%
• PER CAPITA INCOME EXPENDITURE ON PHARMA: 8.5$
• TOTAL PHARMACEUTICAL SPENDING: 1.1 Billion $ (BY
2023)
• MINISTRY OF COMMERCE’S NOTIFICATION 36/2017
RELAXED PROHIBITION ON FOREIGN TRADING
ALLOWING 100% FOREIGN OWNED COMPANIES TO
DISTRIBUTE AND RETAIL CERTAIN LIMITED CATEGORIES
(INCLUDING HOSPITAL PRODUCTS) TO DOMECTIC
MARKET AND OBTAIN IMPORT LICENSE.
• IMCC(INDIA AND MYANMAR CHAMBER OF COMMERCE)
ESTABLISHED TO BOOST TRADE BETWEEN INDIA AND
MYANMAR
 Growth in trade was mainly driven by significant growth in
Myanmar’s imports, which increased close to six-fold in 2018 to
US$ 24.2 billion from US$ 6.3 billion in 2008
 Imports as a percentage of GDP nearly doubled from 18.3 per
cent in 2008 to 35.2 per cent in 2018.
 The total Pharmaceutical spending of Myanmar has been
increasing at a rate of 11 per cent every year and the market
value is expected to reach US$ 1.1 billion by 2023.
COMPETITIVE LANDSCAPE
Myanmar ' Top ten formulation Importing partners
$ Million
Rank Country 2015 2016 2017 Gr% Share%

1 India 65.29 89.34 181.16 102.77 34.44
2 Thailand 38.12 39.04 46.69 19.59 8.88
3 Indonesia 20.76 29.07 32.79 12.79 6.23
4 China 23.27 25.22 27.50 9.05 5.23
5 Rep. of Korea 11.55 12.03 26.92 123.77 5.12
6 France 2.92 6.58 24.31 269.61 4.62
7 Germany 4.74 6.25 20.23 223.66 3.85
8 Bangladesh 6.81 9.82 18.63 89.79 3.54
9 USA 1.65 20.34 18.46 -9.23 3.51
10 Viet Nam 8.41 10.05 15.34 52.65 2.92
World 280.54 345.00 525.93 52.44 100.00
Source:UN comtrade
MARKET SIZE GROWTH ANALYSIS
2022: 656 Million $
2018: 492 Million $

7%
2017: 456 Million $
EPIDEMIOLOGY
CVS DISORDERS
CANCER
DIABETES
HIV
OPPORTUNITIES (MANUFACTURING):
PRODUCT PORTFOLIO
MILD TO MODERATE ANTIBIOTICS
ANTIHYPERTENSIVES
PRAZOLES (PPIs)
ORAL ANTIDIABETICS
LONG ACTING INSULINS

REGISTRATION AND LICENSING REQUIREMENTS
Ø Regulatory Authority : The Food and Drug Administration
(FDA) , Myanmar
Ø Website of regulatory Authority : http://www.fdamyanmar.gov.mm
Ø Fees for Drug Registration : USD 830 approximately

1.Registration Assessment Fees
300,000Kyats + Fees for Laboratory
analysis
2. Registration Fees 500,000 Kyats
Ø Normal time taken for registration : 06-12 Months
Ø RegistrationRequirement : ACTD
[Dossier Format]
Ø Whether plant inspection is mandatory : No
Ø Validity of Registration : 05 Yrs

FDA STRUCTURE
FDA
COSMETIC AND
FOOD CONTROL MEDICAL DEVICE LABORATORY
ADMINISTRATIVE DRUG CONTROL
DIVISION DIVISION DIVISION CONTROL DIVISION
DIVISION
MFDBA
CFDSC
TECHNICAL COMMITTEE: DAC (DRUG ADVSIORY COMMITTEE)
DAC
STATE AND
CENTRAL REGIONAL
INSPECTION
REGISTRATIONS
(MFG & IMPORT)
INSPECTION AND LICENSING
PMS(PHARMACY
(MFG. & IMPORT) INSPECTION,DRUG SAMPLE
PMS COLLECTION AND ANALYSIS,
ADR MONITORING
REGISTRATION PROCESS
DFDA: SAMPLE ANALYSIS AND
LETTER OF INTIMATION FOR DOCUMENT VERIFICATION
REMITTANCE OF ASSESSMENT AND SUBMITS REPORT TO
OF FEE(300,000 KYATS) TO DAC FOR APPROVAL OR ISSUE OF REGISTRATION
FORM 1 DFDA REJECTION CERTIFICATE BY FDA
FDA APPROVAL ACTD + FORM I + SAMPLES + IF APPROVED DFDA ISSUES

COA in less than 60days LETTER OF INTIMATION TO
REMIT REGISTRATION
FEE(500,000 KYATS) TO BE
SUBMITTED WITHIN 90 DAYS
REGISTRATION PROCESS
ACTD VS. ICH CTD
DOCUMENTS TYPE
ICH CTD ACTD
Admin. Docs and MODULE 1 PART I
Product Information
CTD Overview & MODULE II INCORPORATED IN
Summaries PARTS II,III&IV
Quality documents MODULE III PART II
Non-clinical MODULE IV PART III
documents
Clinical documents MODULE V PART IV
THANK YOU
[email protected]

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REGULATORY AND MARKET PROFILE OF MYANMAR

MAAZ AHMED KHAN

4 Population 55,622,506 (July 2018 est.)

5 Population growth rate % 0.89% (2018 est.)

6 GDP (purchasing power parity) $ 329.8 billion (2017 est.)

7 GDP - real growth rate % 6.8% (2017 est.)

8 GDP - per capita (PPP) $6,300 (2017 est.)

10 Population below poverty line 25.6% (2016 est)

11 Age structure % 0-14 years: 26.56%

15-24 years: 17.51%

25-54 years: 43.51%

55-64 years: 7.75%

Source: CIA World Fact Book updated to July 2018

Rank Country 2015 2016 2017 Gr% Share%

2022: 656 Million $

2018: 492 Million $

MILD TO MODERATE ANTIBIOTICS

LONG ACTING INSULINS

Ø Website of regulatory Authority : http://www.fdamyanmar.gov.mm

Ø Fees for Drug Registration : USD 830 approximately

2. Registration Fees 500,000 Kyats

Ø Normal time taken for registration : 06-12 Months

Ø Whether plant inspection is mandatory : No

Ø Validity of Registration : 05 Yrs

FDA APPROVAL ACTD + FORM I + SAMPLES + IF APPROVED DFDA ISSUES

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