by Barbara Unger, GMP Quality Expert, and GMP Regulatory Intelligence Editor-in-Chief
The EMA published their Annual Report for 2016 in May 2017, and it provides highlights of their work in partnership with the national health authorities. Christa Wirthumer-Hoche, chair of the EMA Management Board, provides the Forward to the report, and Guido Rasi, the EMA Executive Director, provides the Introduction. The report identifies important activities in 2016 and how they advance public health. It also holds a collection of graphics from a variety of areas including human and veterinary medicines, the European regulatory network, and inspections/compliance. The report also identifies 22 Annexes that may be found on the Agency’s website but are not included in the report.
It was a busy year with the Brexit decision to leave the European Union posing many challenges to the EMA in the next several years. This process and its ramifications remain a work in progress. Let’s address selected items from the report in turn.
Important EMA achievements in 2016
- Twenty-seven (27) new active substances, those not previously part of an authorized medicine in the EU, were among the eighty-one (81) medicines approved in 2016. The CHMP reached consensus on 94% of these marketing authorization opinions. Further, more than half who received approval had sought and received scientific advice during the product development phase.
- The EMA used tools that provide early access to medicines serving unmet medical needs for more than one-third of the medicines that included a new active substance. These tools include more rapid review and the option of granting a conditional marketing authorization. In the later case, these medicines are subject to post-approval conditions that require the sponsor to generate the complete data that would normally be expected for approval. In addition to approval of novel human medicines, the EMA recommended approval of eleven (11) veterinary medicines, of which six (6) included a new active substance. One-third of the veterinary medicines recommended for approval ‘prevent viral or bacterial infections in food-producing animals.’
- The EMA initiated the PRIority Medicines (PRIME) scheme in the first quarter of 2016. Eighty-four applications were received seeking this identification, which was granted to fifteen (15) medicines. Six (6) oncology products and three (3) haematology-haemostaseology products were granted this classification. CAR T-cells were among the products that received this designation.
- The EMA continues what is a broad approach to development and revision of regulations that include ‘real-world data’, including workshops on ‘big data.’ They also continue to assess the efficiency and effectiveness of the pharmacovigilance efforts in the EU.
- Public health challenges are supported by the EMA and in 2016 included: the spread of the Zika virus and its catastrophic effect on fetal development; efforts to minimize the problems of counterfeit and fake medicines through the implementation of the Falsified Medicines Directive of 2011; and refinements to protect patients during first-in-human clinical studies. The EMA is also working toward increased transparency in providing access to data from clinical studies while simultaneously protecting patient identification.
- The EMA continues to work to strengthen cooperation among the agency and national authorities, healthcare professionals, academics, and industry to ensure optimal regulatory efforts in Europe. This includes stakeholder meetings and additional efforts regarding collaboration opportunities. And, finally, the EMA continues to work to shape the global regulatory environment and ensure optimal use of resources. This includes leadership in global regulatory initiatives and expansion of bilateral agreements.
Advancing Public and Animal Health
This year, work focused on the area of controlling and monitoring antibiotic use, including in food animals. Efforts were taken to ensure confidence in both individual and public health value of appropriate vaccinations. This includes continuing to encourage individuals to receive their annual flu vaccine.
Key Figures in 2016
The graphics and tables provided in this section, beginning on page 47, provide a valuable collection of activities undertaken by the EMA in 2016. Some conclusions:
- Applications for biosimilar products increased to fourteen (14) in 2016 from twelve (12) in 2015 and three (3) in 2014. I expect this will continue to increase.
- In 2016, eighty-one (81) initial evaluations of applications resulted in a positive opinion, sixteen (16) were withdrawn prior to issuance of an opinion and although two (2) were initially given a negative opinion, upon re-evaluation they were recommended to be approved.
- In 2016, essentially half of the requests for accelerated assessment were granted, compared to 25% in 2015 and 20% in 2014. The number of requests received has grown from eight (8) in 2012 to twenty-five (25) in 2016.
- The areas of cancer, infections, cardiovascular, rheumatology and metabolism, (in this order) saw the largest number of medicines recommended for approval in 2016.
- The assessment phase for submission made between 2012 and 2016 averaged 194 days with the range from 179 to 202.
For Compliance and Inspections, the data provided show:
- GMP inspections have increased every year from 368 in 2012 to 672 in 2016. The report states that the 18.5% increase in 2016 over 2015 was associated with the ‘growing number of centrally authorized products.’
- For the 2,293 inspections documented in EudraGMDP in 2016, 24 led to reports of non-compliance. Note this includes more than GMP inspections. Five (5) were associated with EEA/EU based firms; four (4) for China; twelve (12) in India, and three (3) in the US.
- One hundred twenty-one (121) GCP inspections were conducted in 2016, up from eighty-six (86) in 2016. Slightly more than 40% were conducted in EEA/EU countries, just over 25% were conducted in the US, and 16% were conducted in the Middle East/Asia/Pacific areas.
- GCP inspection of two CROs in 2016 lead to suspension or non-granting of MAs for which approval was primarily based on studies conducted at the CRO sites.
- Company notification to the authorities of quality defects ranged from 181 in 2016 to a low of 147 in 2014. These reports led to 16 recalls.
- Eight pharmacovigilance inspections were conducted in 2016.
I encourage readers to peruse the section on key figures for additional information that may be relevant to their specific firms. The report includes additional information on areas not covered in this summary including EMA press releases published around the world, requests for access to documents, and budget execution to name several.
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