Rare Diseases Are Not So Rare

Some have famous fundraising events attached to them, like the Ice Bucket Challenge for ALS or the many walks, runs, and telethons for diseases ranging from Cystic Fibrosis to Muscular Dystrophy. Other conditions, like Wilson’s Disease – a rare condition in which excess copper builds up in the body — are virtually unknown except to the friends and family of those living with the disease. Collectively, there are 7,000 distinct rare diseases, which, according to the advocacy group Global Genes, affect up to 400 million people globally. About half of those diagnosed with a rare disease are children.

Continue reading

How to Renew Plant Protection Products – EU Regulations

The legislation concerning the placing of PPPs on the European single market is enshrined in Regulation (EC) No. 1107/2009, with the specific data requirements for ASs and PPPs contained in Regulations (EU) No. 283/2013 and No. 284/2013. The authorization of ASs generally expires after ten years. To enable continued marketing and sales of PPPs, a renewal of authorization of the ASs must be sought. This renewal procedure is covered by Commission implementing Regulation (EU) No. 844/2012 and is a European-level process.

Continue reading

Honoring African American History Month: Recognizing Contributions from One of Our Own Community-Builders

National African American/Black History Month recognizes the accomplishments of African Americans who have made a difference in our society. Many notable African American physicians, engineers, scientists, and nurses have contributed to medical and scientific breakthroughs and continue to serve as role models for students of color interested in pursuing careers in the STEM (science, technology, engineering and mathematics) fields.   

Continue reading

Expediting SEND Datasets for an International Regulatory Submission

A case study with Peg Biomedical Co., Ltd

Peg Biomedical Co., Ltd. (Peg Bio), is a Suzhou, China-based biopharmaceutical company specialized in developing innovative medicines for metabolic diseases including type 2 diabetes, obesity, and non-alcoholic hepatitis.

While business between Peg Bio and Covance first started in 2014, the strength and depth of our relationship was highlighted in Spring 2019.  In May that year, more than 400 Covance employees relocated to a new facility – the Aland Center in Zhangjiang Hi-Tech Park of Shanghai’s Pudong District-  and Dr. Michael Xu, CEO of Peg Bio, was invited to deliver a speech for the new site opening ceremony. In his address, Dr. Xu expressed his gratitude for Covance’s service delivery, “among all of the collaborators, Covance is probably the best time‑keeping CRO we have worked with.”

Continue reading

Covance Opens New State-of-the-Art Genomics Laboratory in Indianapolis

Covance celebrated the grand opening of its new flagship Genomics Lab in Indianapolis, Indiana on February 14th. Co-located with its established, industry-leading Central Laboratory and Bioanalysis Lab, the site provides greater testing efficiencies and comprehensive scientific solutions to help biopharmaceutical companies develop therapies faster and with a greater probability of success.

The new Genomics Lab adds 16K ft2 of new, dedicated laboratory space to deliver applied genomics solutions from single target to whole genome analysis. The laboratory also consolidates exploratory studies and biomarker development, patient management (CAP/CLIA) laboratory testing and Companion Diagnostic (CDx) development.

Continue reading

Understanding Biocidal Products Regulation (BPR) in the EU

BPR is the legislation governing the use of biocidal products in the European Union. Read on to find out how to navigate the authorization process and understand the information required.


Biocidal products are used to control unwanted organisms (e.g., pests, such as rats, or micro-organisms, like bacteria) that are harmful to the health of humans or animals, the environment, or that cause damage to . As such, biocides play an important role in everyday life and reflect a huge range of product types, from disinfectants to insecticides.

The European Chemicals Agency (ECHA) regulates the specific biocide products that are available in the EU/EEA and Switzerland, as well as the active substances that they contain, under the Biocidal Products Regulation (BPR). The aim of the BPR is to ensure that all marketed biocidal products perform their intended role (i.e., have efficacy) and pose a low hazard to humans, animals and the environment when used as specified.

Quick Overview of BPR

The EU Biocides Regulation 528/2012 has been in effect since September 2013. It has a two-step process requiring at first an active substance application, and secondly the authorization of any biocidal products containing that active substance. The regulation also allows for the authorization of biocidal products as a biocidal product family. A product family allows the authorisation of multiple biocidal products within one submission. All products within the family must contain the same active substance(s) but can appear at different concentrations. If your product is identical to an existing formulation, but marketed under a different trade name, it is possible to apply for a same biocidal product authorization, which can reduce administrative burden.

You can choose to authorize products at a national level (which is beneficial in cases where the product is marketed in a few EU/EEA countries) or at Union level (which covers the entire EU/EEA and Switzerland). Up to the end of 2017, total of 115 Union authorizations for biocidal products had been submitted – of these 83% were submitted for biocidal product families. This may illustrate the attraction of the lower administrative burden and cost associated with a product family authorization.

Union and National authorization require submission via R4BP to a competent authority in a member state. There are some practical and logistical variations in how different member states approach BPR, so it’s worth considering the options available to you before you settle on a specific one.

Biocide Categories and Product Types

Annex V of the BPR contains 22 different product-types (PT) which fall into four main groups;

  • Disinfectants (PTs 1–5): for disinfectants in human and veterinary hygiene, surface disinfectants, drinking water disinfectants and for disinfectants that may enter into contact with food
  • Preservatives (PTs 6–13): biocides used to maintain product shelf-life (other than food or feed), protect construction materials or textiles, preserve wood and prevent slime growth
  • Pest control (PTs 14–20): for rodents, birds, fish, molluscs and insects
  • Other: for biocidal products which don’t fit within the other groups and include antifouling products (PT 21) and embalming fluids (PT 22)

Union Authorization (UA) is not an option for active substances within PTs 14, 15, 17, 20 and 21. Union authorization becomes an option for PTs 7-13, 16 and 22 from January 1, 2020 with all remaining PTs currently able to apply for UA.

Testing Under BPR

For authorization of a biocidal product, you need to provide all the information requirements set out by ECHA. There are two main data sets which are included within the IUCLID dossier – the core dataset (CDS), which all products require, and the additional dataset (ADS), which depends on the PT, its use, type of formulation and application method. Table 1 summarizes the analytical requirements, for both CDS and ADS, for biocidal products and active substances.

Table 1: CDS and ADS analytical methods for active substances and biocidal products

In addition to the IUCLID dataset, a risk assessment and a summary of product characteristics (SPC) are also required. The most time-consuming data to collect relates to long-term stability. These tests take two years to conduct, so forward planning for BPR submission is essential.

Conclusions

There are multiple things to consider when navigating your biocidal product through BPR – focus on gathering the right information and selecting the most appropriate authorization approach for your product, and consider the value of the biocidal product family approach.

Visit our website for more information about Covance’s regulatory services for crop protection.


About the Author

David’s main focus and area of expertise is biocides regulations, including regulatory advice and strategy. The latter often involves preparing documents such as data gap analysis, or setting up and identifying the format of product families.

Taking International Women’s Day to New Heights

While International Women’s Day (IWD) is officially recognized on March 8, the collective action and shared ownership necessary to drive gender parity is a constant undertaking. Last year, our drug development team located in India took the “Balance for Better” theme to heart. This year, they’re planning for an even more impactful 2020 that’s part of a commitment to make a positive difference for women across all of our global sites.

Continue reading