10 Small Submissions
No more than 10 Documents per submission
The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way. In brief, Health authorities such as the National Health Surveillance Agency of Brazil (ANVISA) and the Food and Drugs Administration (FDA) have taken effective measures to increase the safety of the products by strengthening the regulations. In addition, authorities such as the China Food and Drug Administration (CFDA) and European Medicines Agency (EMA) have released new guidelines for classification of medical devices to help clarify grey areas.
Throughout the year, keeping abreast with Regulatory market dynamics, we have reported some, if not all, the mandates and updates in our blogs. Now, as 2018 is coming to an end, let’s give you a quick recap of all the Regulatory changes, industry-wise and function-wise that have taken place so far.
New identities for Health Authorities: From 1st September 2018, the official English name of the State Food and Drug Administration of China has been changed to National Medical Product Administration (NMPA). Additionally, on February 12, 2018 South Africa’s Minister of Health appointed South African Health Products Regulatory Authority (SAHPRA) as its new Regulatory authority.
FDA Released New Guidance Document for Generic Drugs: In 2018, FDA released one revised and one new draft guidance to advance the development of generic transdermal and topical delivery systems (TDS) to align the number of approvals of generic drugs. The drafts states:
ISO Revised Implementation Guidelines for ISO 11238: To keep up with the changes taking place as a result of Brexit, ISO updated its ISO/TS 19844, “Implementation guidelines for ISO 11238 for data elements and structures for the unique identification and exchange of regulated information on substances”. The updates comprise of details for agencies and vendors working on the substance repositories on Substance Groups 1 to 3. The details are:
TGA Approved new Product Information (PI) Form: From 1st January 2018, TGA has approved a new Product Information (PI) form with a transition period of 3 years. The changes were adopted to ensure that critical information is more accessible. These changes include bringing critical information into the light and to align headings and sub-headings with the international standard.
FDA strengthens Pregnancy, Lactation and Labeling Rule (PLLR): USFDA’s regulations for Pregnancy, Lactation and Labeling Rule (PLLR) are into effect since June 2015. But recently, to focus more on the content and format of Physician Labeling Rule (PLR), FDA has updated the guidelines. The changes are made under new subsections: 8.1 Pregnancy, 8.2 Lactation and, 8.3 Females and Males of Reproductive Potential of USE IN SPECIFIC POPULATIONS section of the full prescribing information (FPI).
TGA enforced eCTD V3.1 Module 1 Specification: Therapeutic Goods Administration (TGA) of Australia has rolled out a new mandate to use latest version 3.1 Module 1 Specification for Regulatory submissions post June 30th, 2018.
TGA has initiated accepting submissions adhering to version 3.1 from the day it has come to effect in action i.e., Jan 1st, 2018. And at the same time, the agency has also provided transition time to align with the latest version. Submissions made, based on both versions (3.0 & 3.1) will be accepted until the deadline which is on June 30th, 2018, after which it will be deemed a mandate to adhere to the latest version (3.1).
FDA Made Submission of DMFs In eCTD Format Compulsory: From 5th May 2018, FDA has made it mandatory for manufacturers to submit Drug Master Files (DMFs) in eCTD format. The mandate states:
United States Pharmacopeia’s latest guidelines on Elemental Impurities: As of 1st January 2018, new applicants submitting NDAs and ANDAs for drug products need to fulfill recommendations as per the guidelines by ICH (International Conference for Harmonization) Q3D imposed by United States Pharmacopeia (USP). The recommendations are:
TGA started accepting electronic submissions for Certificate of Free sale or Export Certificate: In response to the issues faced by the sponsors while notarizing and endorsing certificate of free sale or export certificate, TGA announced that all medical devices are required to submit their application and receive the certificate electronically. The mandate will help the sponsors to meet the needs of the importing country.
Eligibility criteria for the Certificate
CFDA released new classification catalog for medical devices: Effective from 1st August 2018, the China Food and Drug Administration - CFDA (currently National Medical Product Administration – NMPA) has released a new mandate which classifies medical devices on the basis of device category and sub-category. The new classification will affect everyone applying for registration of medical devices, be it new applicant, existing manufacturers (in case of renewals) or reclassification. The new catalog suggests the following prime changes:
EU MDR Timelines Revised: To enhance the compliance standards for device manufacturers and other stakeholders, EU’s new Medical Device Regulations (MDR) - 2017/745-MDR and 2017/746-IVDR came into effect from May 25, 2017. The new regulations consist of 123 articles and 22 rules for classification of device. While the regulations are still in transition, the timeline for the year 2018 are:
EC updated the classification of borderline medical devices: This year, European Commission released a newly updated manual to help manufacturers classify borderline medical devices and products. This 18th revision of the manual supports case-by-case classification and is aligned with MEDDEV 2.1/3 Rev. 3. The new classification and consideration includes:
ANVISA Simplified Regulations for Children’s Cosmetics: ANVISA modified resolution RDC 07/2015 to simplify regulations related to children’s cosmetics. The new mandate allows manufacturers to launch a product in the market before it is registered. The main changes in the resolution are:
ANVISA Regulated Different Label Variations for the Same Product: On 22nd November 2018, ANVISA published a new standard - Resolution RDC 250/2018 related to Cosmetics Labeling in Brazil. The new regulation allows product manufacturers the flexibility to regulate different labeling variations for the same product. With this regulation coming into effect, labeling changes related to only safety and benefits of the product will require submission to the agency.
To conclude, the year 2018 has brought a lot of Regulatory changes that impacted the life sciences industry. And to make the manufacturers and sponsors confident and compliant in taking their products globally, Freyr, as a strategic Regulatory partner, has been successful in educating and assisting the industry through our webinars, blog posts, newsletters, and journal articles. Our recent achievement of surpassing 300+ clients and other acknowledgments stands a testimony to the same.
Considering the pace at which the mandates are changing, we look forward to the updates and guidance documents that are expected to be released in 2019 and for sure will inform you as always for successful compliance. Stay tuned to this space for 2019 and Farther Regulatory updates. Stay informed to stay compliant.