22 June 2016 EMA/425176/2016 Information Management Division

Monthly statistics report: May 2016 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, 2016. Reproduction is authorised provided the source is acknowledged.

Table 1. Pre-authorisation: Marketing-authorisation applications* 2013

2014

2016†

2015

Started Finalised Started Finalised Started Finalised Started Finalised

Non-orphan medicinal products

48

46

37

42

36

41

17

15

Advanced-therapy medicinal products

0

2

1

0

0

1

0

0

Paediatric-use (PUMA) products

1

0

0

1

1

0

0

1

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

6

4

12

15

8

7

1

1

Generic products

5

16

25

6

28

25

7

8

Similar biological products

1

4

3

3

12

2

2

1

61

72

78

67

85

76

27

26

16

14

20

17

24

20

10

6

2

0

1

1

1

1

1

1

79

86

99

85

110

97

38

33

New products

Sub-total product applications 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Finalised applications exclude applications withdrawn prior to opinion.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: May 2016 EMA/425176/2016

Page 2/5

Table 2. Pre-authorisation: Outcome of the evaluation of marketing authorisation applications* 2013

2014

2015

2016

79

81

93

31

4

4

3

2

3

1

3

0

Negative opinions

7

4

4

2

Opinions after accelerated assessment**

5

7

5

5

Applications withdrawn prior to opinion

8

6

5

3

10

5

1

1

3

1

0

0

Positive opinions Opinions recommending conditional ** marketing authorisation Opinions under exceptional ** circumstances

Re-examinations requested Re-examination - 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: May 2016 EMA/425176/2016

Page 3/5

Table 3. Scientific services 2013

2014

2015

2016



Started Finalised Started Finalised Started Finalised Started Finalised

Compassionate-use opinions

2

2

1

1

0

0

0

0

Art. 58 (WHO) scientific opinions

1

1

1

1

1

1

0

1

3

1

0

1

1

1

0

0

19

13

16

16

17

19

6

12

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: May 2016 EMA/425176/2016

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Table 4. Post-authorisation: Variations, renewals and annual reassessments 2013

2014

2016†

2015

Started

Started

Started

Finalised

Started

Finalised

Type IA variations

2,922

2,886

2,969

2,854

2,829

2,849

Type IB variations

1,958

1,597

1,886

1,986

1,954

1,838

786

857

Type II variations

961

946

1,151

1,103

1,168

1,097

425

465

Extensions of marketing authorisation

16

18

16

15

14

15

7

7

Annual reassessments

18

16

18

18

16

20

7

11

Renewals*

98

77

100

121

71

75

46

38

*



Started

Finalised

1,312 1,249

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: May 2016 EMA/425176/2016

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Monthly statistics report: May 2016: medicinal products for human use ...

Jun 22, 2016 - Information Management Division. Monthly ... This document provides current information related to the volume and evaluation of marketing.

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