Compliance Resources to Help you Stay Current

ICH Q3D Elemental Impurity Guidelines: Are You Prepared for January 2018?

While both ICH Q3D and USP General Chapters <232> and <233> are scheduled to go into effect in 2018, implementation requires extensive prior work. The new elemental impurities limits require more sophisticated analytical technology, such as ICP-MS, not routinely used in QC labs. The ultra-sensitive analytical method must be validated specifically for all of your different dosage forms.

Drug Master Files: All You Need to Know

Drug Master File (DMF) is a package of confidential, proprietary assets, detailing the formulae, processes, materials, test methods, and other information relevant to the manufacture of product used in the composition, packaging, and/or processing of pharmaceuticals and/or biologics. Though there are no regulatory requirements to file a DMF, the benefit of its use is overwhelming. A DMF filing help firms maintain confidentiality of proprietary information and yet ensure compliance with regulatory requirements for disclosure of product details.

340B Drug Pricing Program: Obama Administration Issues Much Awaited Final Rule

The Health Resources and Services Administration (HRSA) within HHS has lately issued a final rule that imposes civil monetary penalties on drug manufacturers for overcharging hospitals and clinics covered under 340B drug discount program. The HHS initially proposed the rule in June 2015, opened for comment and then extended the comment period.

The US FDA recently held a 2-day public hearing to seek input for more flexible regulations on off-label promotion for drugs and devices. Pharmaceutical, medical device, and insurance industries, health and safety advocates, as well as physicians and patients packed a room for two full days at the FDA’s campus to debate on these rules and regulations.

Dr. Robert Califf, the FDA commissioner, said that ultimately, the analysis of the regulations is to ensure that the system "best protects and promotes the public health and the well-being of patients."

Pharmaceutical companies stated that current marketing regulations are too restrictive.

Patients argued that relaxing these regulations would be a "public health disaster."

While regulators point out that the key to making profits in the pharmaceutical industry is innovation and breakthrough, they are left investigating an alternative that several industry giants seem to explore - price collusion.

Drug pricing practices in the pharma industry have drawn a lot of flak from various quarters and now lawmakers are turning their attention to this emerging trend. Price hikes at Valeant Pharmaceuticals, Mylan, and others are under close scrutiny, while federal antitrust regulators probe whether Merck & Co Inc, Sanofi SA, Novo Nordisk A/S, and Eli Lilly and Co colluded to fix prices for insulin and other diabetes drugs.

Elemental impurities have been topic of discussion since 2009 when the ICH commenced work to provide an international standard to limit the impurities in drug products and ingredients. FDA too has released its guidance on the control of elemental impurities in consistent with the implementation of ICH’s Q3D Elemental Impurities guideline. The FDA guidance also addresses the United States Pharmacopeial Convention’s (USP’s) requirements which go into effect on January 1, 2018.

Pharmaceutical Quality by Design (QbD): Understanding its Principles

Quality is a prime factor of importance in this era of competition. More and more pharmaceutical companies today are embracing the principles of Quality by Design (QbD) for development and manufacturing. The principles of quality have been defined by three the ICH guidelines: Q8 on pharmaceutical development, Q9 on quality risk management and Q10 on pharmaceutical quality system.

QbD is a recent concept which has been included as an annex to ICH Q8 Guidance. QbD enables better process understanding, and a more scientific approach to development rather than mere testing of the final product.

Malaysian Health Ministry Bans 10 Cosmetic Products

The Health Ministry in Malaysia has banned 10 cosmetic products, and advised the consumers to be more vigilant while purchasing the products online. Its deputy minister, Datuk Seri Dr Hilmi Yahaya said, “Every shop has the scanner and buyers can scan the product. If the hologram does not appear, it means that the item does not have the ministry’s approval. I urge everyone to be careful as selling of fake cosmetics via the Internet is on the rise.”

In January the European Parliament's committee responsible for public health voted in favour of a revised version of the EU Clinical Trial Regulation initially proposed by the European Commission in July 2012.

International companies looking to protect their intellectual property in India were dealt a blow today when the country's Supreme Court denied a patent application for a best-selling cancer drug from the Swiss drugmaker Novartis. On the other hand, medical charities and poor countries that depend on generic drugs were cheering the decision.

GSK’s new medicine for treating Lupus – Benlysta (generically known as ‘Belimubab’) was rejected by the UK National Health Service’s (NHS) drug rationing body. The drug was discovered by Human Genome Sciences and developed by Glaxo SmithKline (GSK) to combat the disease that causes the immune system to attack joints and organs. This article details why the drug was rejected and outlines the NHS drug approval process.

Non-prescription (OTC) drugs marketed without an approved application are also subject to adverse event reporting requirements, under section 760 of the Federal Food, Drug, and Cosmetic Act. A report of each adverse drug experience which is both serious and unexpected must be made to the Agency, as soon as possible, but no later than 15 days, after receiving information about the event.

An original drug manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as the reference drug. This has led to an outcry from patients and drug manufacturers as generics makers cannot be held legally responsible for any product defects. Both groups are demanding a change in current generics warning label regulations by the FDA.

Drug shortage in the US is going global, as the pharmaceutical industry is increasingly globalised, shortages in one country will affect others. In 2011, according to FDA, as many as 250 drug shortages have been traced, and a total of 195 drug shortages were prevented, as the Agency has taken proactive steps needed to increase available supply for patients in the U.S.

On Feb 28 2012, the FDA released new draft guidance on safety changes for widely used cholesterol – lowering or statin drugs. These regulations aim to educate, update health care professionals and patients about the health benefits as well as risks associated with these drugs.

On February 9, 2012, the FDA released draft guidelines about quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and are based on key scientific and regulatory factors which should be considered for submission of applications for bio-similar products to the FDA.

On February 9, 2012, the U.S FDA released draft guidelines about scientific and quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and provide an overview of FDA’s approach in determining bio-similarity of a biologic product.

In Australia, advertisements for therapeutic goods that are directed at consumers should get approved before broadcasting or publication and must comply with Therapeutic Goods Advertising Code.

This article gives an overview and summary of requirements of the code.

No – Over-the-Counter or OTC drugs are not covered by the Centers for Medicine and Medicaid Services’ (CMS) newly proposed Physician Payment Sunshine rule.

According to the Act and proposed rule, the requirements apply to manufacturers of a “covered drug, device, biological, or medical supply."

A covered drug, device, biological or medical supply refers to any drug, biological product, device, or medical supply for which payment is "available" under Medicare, Medicaid, or CHIP.

Over-the-counter (OTC) drugs and biologicals are not covered by this rule.

Read an overview and summary of requirements of the proposed rule.

Yes – but only payments above $10 made to covered recipients (i.e., physicians or teaching hospitals) have to be reported by manufacturers under the proposed rule, part of the enforcement requirements included in the Physician Payment Sunshine Act of 2010. This rule has been drafted by the Centers for Medicine and Medicaid Services (CMS), which has been tasked by the government to enforce the Act’s requirements.

For failing to report, manufacturers will be subject to a civil monetary penalty of not less than $1,000, but not more than $10,000, for each payment or other transfer of value or ownership or investment interest not reported.

For knowingly failing to report, manufacturers will be subject to a civil monetary penalty of not less than $10,000, but not more than $100,000, for each payment or other transfer of value or ownership or investment interest not reported.

Read an overview and summary of requirements of the proposed rule.