To be able to market a medicinal product for human use, a pharmaceutical company requires a marketing authorisation. In the Netherlands, the MEB supplies these authorisations for regular medicinal products, and botanicals (herbal medicinal products).
The MEB aims to play a leading role in the assessment of new medicinal products within the European network of medicines authorities. With its strong representation in European committees and working groups, the MEB involves the interests and needs of Dutch patients in European decision-making. The MEB was able to give an extra boost to this in 2016 with the Netherlands’ EU presidency. The MEB is working on its goal of making available innovative medicinal products that are important for patients more quickly.
Through Centralised European procedures, 27 new substances for medicinal products were authorised in 2016. The Netherlands was a Rapporteur or Co-rapporteur in 25 centralised European procedures in 2016, amounting to 10% of the total number of Centralised procedures. For 457 completed Decentralised procedures (DCPs), the Netherlands was the Reference Member State (RMS). The Netherlands provides the most RMS applications in Europe as a reference Member State in the Mutual recognition procedure (MRP) or Decentralised procedure (DCP). That amounts to over 15% of the total number of MRPs and DCPs. In addition, there were 55 applications via the National procedure.
The year 2016 was once again a busy year for the MEB. There was a further increase of about 10% in the number of concluded procedures (see graphs below).
In 2016, there was a lot of attention for issues related to product defects and medicinal product shortages; this is also an important focus area for Europe. An example is the shortage of the thyroid medicinal product Thyrax Duotab (levothyroxine) that occurred from February 2016. Widely covered in the media, Thyrax is still in short supply. The MEB considers this a worrying situation and has asked the pharmaceutical company concerned to provide a solution as soon as possible. There was also intensive consultation with umbrella organisations of care providers and patients, and the MEB has also made specific recommendations in this context.
Many procedures concerned an extension of the indications. An example of this is Opdivo. In 2015, the CHMP approved this product in Europe for the treatment of melanoma (skin cancer). The Netherlands was a Co-Rapporteur in this procedure. This product was also approved for the treatment of lung cancer in September. In the course of 2016, 6 indication extension requests were submitted, of which 2 have been approved so far. Additional indication extensions are also expected for 2017 and the following years.
Here is an overview of several important figures. This is not a complete reflection of all activities falling under medicinal products for human use.
Appendix A: Authorised medicinal products for human use with a new active substance in 2016
Key figures regular medicinal products
Medicinal products may be brought onto the market via a Centralised procedure (CP), a Decentralised procedure (DCP), a Mutual recognition procedure (MRP), or a National procedure.
Medicinal products with a new active substance authorised via the Centralised procedure
| Authorised medicinal products new active substance | |
|---|---|
| 2016 | 27 |
| 2015 | 43 |
| 2014 | 35 |
| 2013 | 40 |
| 2012 | 26 |
New applications via the Decentralised procedure (DCP)
| DCP-RMS | DCP CMS | |
|---|---|---|
| 2016 | 457 | 280 |
| 2015 | 479 | 356 |
| 2014 | 514 | 334 |
| 2013 | 377 | 234 |
| 2012 | 476 | 307 |
The number of applications via the Decentralised procedure in Europe has slightly increased relative to 2015. The number of applications with the Netherlands as Reference Member State (RMS) has however seen a slight decrease; the MEB does handle most of the RMS applications within Europe (>15% of the total number). The number of Decentralised procedures with the Netherlands as Concerned Member State (CMS) has also decreased relative to 2015.
New applications via the Mutual recognition procedure (MRP)
| MRP RMS | MRP CMS | |
|---|---|---|
| 2016 | 2 | 69 |
| 2015 | 2 | 58 |
| 2014 | 16 | 32 |
| 2013 | 6 | 36 |
| 2012 | 10 | 67 |
The number of MRP procedures with Netherlands as Reference Member State has remained constant, while the number of MRP applications with the Netherlands as CMS has increased relative to 2015.
New applications via the National procedure
| New marketing authorisations | Parallel import products | |
|---|---|---|
| 2016 | 55 | 437 |
| 2015 | 112 | 390 |
| 2014 | 147 | 338 |
| 2013 | 141 | 367 |
| 2012 | 181 | 393 |
The number of applications via the National procedure (including duplex applications) has decreased considerably relative to previous years. The number of national applications for parallel import products has increased relative to 2015.
Authorised medicinal products
| Authorised medicinal products | |
|---|---|
| 2016 | 14011 |
| 2015 | 13851 |
| 2014 | 14023 |
| 2013 | 14271 |
| 2012 | 14017 |
The toal number of authorised medicinal products has slightly increased relative to 2015. In the Netherlands, the number of products for which a marketing authorisation has been granted has remained constant around 14,000 for years.
Number of completed procedures
| Number of completed procedures | |
|---|---|
| 2016 | 25480 |
| 2015 | 23274 |
| 2014 | 19765 |
| 2013 | 22077 |
| 2012 | 21931 |
The number of completed procedures has strongly increased in 2016.
New marketing authorisations
| New marketing authorisations | Parallel import products | |
|---|---|---|
| 2016 | 792 | 413 |
| 2015 | 833 | 313 |
| 2014 | 742 | 311 |
| 2013 | 853 | 379 |
| 2012 | 1022 | 373 |
The number of new marketing authorisations (National, Duplex, MRPs and DCPs) on an annual basis has again decreased in 2016, after an increase in 2015. As regards national marketing authorisations for parallel import products, the number has strongly increased in 2016 after a previous decrease and stabilisation.
Variations in existing marketing authorisations
| Number of variations to existing marketing authorisations | |
|---|---|
| 2016 | 12810 |
| 2015 | 13496 |
| 2014 | 12477 |
| 2013 | 12895 |
| 2012 | 12118 |
The number of procedures where a variation is implemented in the authorised dossier has decreased in 2016 relative to 2015.
Marketing authorisation refusals
| Number of products for which the application procedure has led to a refusal | |
|---|---|
| 2016 | 4 |
| 2015 | 7 |
| 2014 | 2 |
| 2013 | 4 |
| 2012 | 7 |
In the majority of cases, the handling of applications for a marketing authorisation by the MEB leads to adjustments in the dossier as a result of questions and requirements that the MEB sets during the application process. This may include adjustment to applications for indications, dosages, formulations, the production process or any other part of the dossier relevant to the prescriber and the patient. The number of applications that leads to a full refusal is relatively low and has been less than 10 annually for years. These are applications that actually lead to a refusal. The number of applications that are withdrawn by the applicant during the procedure, is higher (not displayed).
Withdrawals of marketing authorisations
| Marketing authorisations | Parallel import products | |
|---|---|---|
| 2016 | 613 | 441 |
| 2015 | 667 | 646 |
| 2014 | 724 | 376 |
| 2013 | 758 | 220 |
| 2012 | 1000 | 583 |
This graph illustrates the number of requests for withdrawal of existing marketing authorisations. In 2016, the number of requests for withdrawal has decreased relative to 2015. For parallel import products, the number of requests to withdraw existing marketing authorisations has decreased considerably in 2016, after a strong increase in 2015.
Role of the Netherlands in European committees
| NL coordinator Scientific Advice | NL Rapporteur Paediatric Investigation Plan | NL (Co-)Rapporteur CHMP | NL Rapporteur orphan medicinal product status | NL (Co-)Rapporteur CHMP referral | NL Rapporteur PRAC | |
|---|---|---|---|---|---|---|
| 2012 | 55 | 44 | 26 | 10 | 1 | |
| 2013 | 69 | 37 | 15 | 9 | 6 | |
| 2014 | 72 | 35 | 24 | 13 | 5 | 11 |
| 2015 | 86 | 46 | 22 | 8 | 9 | 17 |
| 2016 | 101 | 23 | 18 | 21 | 6 | 13 |
This overview illustrates the strong representation of the MEB at the European Medicines Agency (EMA). The MEB has a large role in important European procedures and influential committees. Relative to the previous year, the number of rapporteurships or coordinatorships has increased for scientific advice and allocation of Rapporteur orphan medicinal product status (see figures below) and PRAC procedures. The number of CHMP rapporteurships, CHMP referral procedures and Paediatric Investigation Plans (PIPs) have decreased.
