8 February 2018 EMA/85286/2018 Information Management Division

Monthly statistics report: January 2018 Medicinal products for human use (cumulative figures for the year to date)

This document provides current information related to the volume and evaluation of marketing authorisation and post-authorisation applications for medicinal products for human use received by the European Medicines Agency. The purpose is only to provide ongoing factual information. Commentaries and analysis are provided in the Agency's annual reports.

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

Table 1. Pre-authorisation: Marketing-authorisation applications* 2015

2016

2017

2018†

Started Finalised Started Finalised Started Finalised Started Finalised

Non-orphan medicinal products

36

41

40

28

32

33

0

6

Advanced-therapy medicinal products

0

1

0

0

0

1

0

0

Paediatric-use (PUMA) products

1

0

1

1

2

1

0

0

Well-established use, abridged, hybrid and informed consent products

8

7

7

5

5

6

0

0

Generic products

28

25

24

22

10

22

0

0

Similar biological products

12

2

14

7

17

14

0

1

Sub-total product applications

85

76

86

63

66

77

0

7

24

20

27

16

19

20

1

1

1

1

1

2

4

1

0

0

110

97

114

81

89

98

1

8

New products

Orphan medicinal products◊ New products Advanced-therapy medicinal products Total product applications

* Finalised applications exclude applications withdrawn prior to opinion. † Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year. ◊ These figures reflect the orphan status of the medicinal products at the time of the CHMP opinion. EMA’s Committee for Orphan

Medicinal Products (COMP) then assesses whether the orphan designation should be maintained.

† Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year.

Monthly statistics report: January 2018 EMA/85286/2018

Page 2/5

Table 2. Pre-authorisation: Outcome of the evaluation of marketing authorisation applications* 2015

2016

2017

2018†

93

79

92

7

Opinions recommending conditional marketing authorisation**

3

7

3

0

Opinions under exceptional circumstances**

3

1

2

1

Negative opinions

4

2

6

1

Opinions after accelerated assessment**

5

7

7

1

Applications withdrawn prior to opinion

5

16

14

2

Re-examinations requested

1

2

5

0

Re-examination - Positive opinions

0

2

0

0

Positive opinions

* Applicants can request a re-examination. The first four rows present the outcome of the evaluation before a re-examination (or a

re-consideration). The final row shows the number of changes from a negative to a positive opinion following a re-examination or a re-consideration. ** Included in the figures for positive opinions.

† Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year.

† Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year.

Monthly statistics report: January 2018 EMA/85286/2018

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Table 3. Scientific services 2015

2016

2018†

2017

Started Finalised Started Finalised Started Finalised Started Finalised

Compassionate-use opinions

0

0

0

0

0

0

0

0

Art. 58 (WHO) scientific opinions

1

1

0

1

1

0

1

0

1

1

0

0

2

1

0

1

17

19

19

22

22

24

1

1

Opinions on ancillary medicinal substances in medical devices* Plasma master file (includes initial certification, variations and annual re-certification)

* Consultation in accordance with Council Directive 93/42/EEC concerning medical devices as amended by Directive 2000/70/EC as

regards medical devices incorporating stable derivates of human blood or plasma and Directive 2001/14/EC. † Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year.

Monthly statistics report: January 2018 EMA/85286/2018

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Table 4. Post-authorisation: Variations, renewals and annual reassessments 2015

2016

2017

2018†

Started

Finalised

Started

Finalised

Started

Finalised

Started

Finalised

Type IA variations

2,829

2,849

3,019

2,934

3,080

3,069

236

208

Type IB variations

1,954

1,838

2,000

1,988

2,054

1,975

174

194

Type II variations

1,168

1,097

1,185

1,131

1,133

1,116

82

92

Extensions of marketing authorisation

14

15

25

16

21

25

0

1

Annual reassessments

16

20

25

19

19

22

2

1

Renewals*

71

75

107

89

94

90

4

4

* Includes renewals of conditional marketing authorisations.

† Figures for the current year are cumulative, year to date. Figures for preceding years are totals for the year.

Monthly statistics report: January 2018 EMA/85286/2018

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January 2018 - European Medicines Agency - Europa EU

Feb 8, 2018 - 30 Churchill Place ○ Canary Wharf ○ London E14 5EU ○ United Kingdom. Telephone +44 (0)20 3660 6000 ... This document provides current information related to the volume and evaluation of marketing authorisation and ... The purpose is only to provide ongoing factual information. Commentaries and ...

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